Department of Pharmacy 2012
1 Compendium of Research
Message of Principal
I am pleased to present first annual research compendium of Department of Pharmacy
which a compilation of research and development activities conducted in a calendar year.
This compendium comprises of detailed information of the publication, ongoing and
completed research projects by the students and the faculties.
Department of Pharmacy is an institute devoted to conducting, supporting, and
encouraging research. It has a well established research facility to achieve the goals of the
department in the field of research. In order to give impetus to the research activities we
have well qualified faculties and the good resource centre at our central library. This is the
first research annual compendium which reflects our strength and hard work showing
inclination of the students and the faculty towards the research in various fields of
pharmacy. No doubt, there were many challenges came in fulfilling this goal but the
enthusiasm of our dedicated faculties overcome all hurdles to achieve their
accomplishment. I assure that this commitment of the faculties of the department will be
continued in the time to come. I would like to compliment all the researchers and the
researcher scholars who have contributed their knowledge and the novel research ideas at
the department. I also congratulate the compilation team to bring this compendium as the
ready reference of our dedication towards research and development.
Dr. A K Seth
Principal / HOD,
Department of Pharmacy,
Sumandeep Vidyapeeth,
Piparia, Vadodara
Department of Pharmacy 2012
2 Compendium of Research
Contents
Sr. no Title Page no. 1 Research Policy 2 Ongoing research projects 3 Completed research projects 4 Published papers
Department of Pharmacy 2012
3 Compendium of Research
Research Policy
Introduction
This policy establishes the research environment within which academic staff and postgraduate
research students carry out their research. It also provides an overarching framework for the
development and implementation of all research management at Sumandeep Vidyapeeth
Objectives
To develop a proactive mechanism for smooth implementation of research projects.
To promote research culture among the staffs and students of the university.
Simplification of procedures like sanctions/purchases for research projects and other aspect.
To motivate researchers to apply for external funding agency.
To promote the publication from all research projects.
Practices
Central research committee circulates the notification regarding inviting research projects
from the students and staff of each constituent unit of university twice in a year.
Interested candidates write a research proposal in the prescribed format provided by central
research committee and submit it to central research committee in given time limit.
Research scholar can also apply for the research fellowship/ financial assistance / grant to
university / External agency as per procedure guideline given by central research committee.
Central research committee reviews the research projects thoroughly scrutinizes the
submitted projects, identifies the need of research projects & thrust areas of research project
submitted by research student/faculty/scholar of the respective department.
The research projects which fulfill the entire criterion and satisfy the research thrust
possessing will be considered for funding.
The Central research committee will call external experts for reviewing of projects.
The principal investigator has to obtain the SVIEC permission before commencement of the
research work.
The Principal investigator should commence his/her project at the pre-decided date and
complete in a stipulated time period.
The Principal investigator must follow the SV instrument purchase procedure for any
procurement of instrument/equipment.
Department of Pharmacy 2012
4 Compendium of Research
Minimum one fourth grant will be disbursed at the initial stage and subsequently further
installments will be disbursed on submission of utilization certificate along with bills and
account statement of the previous grant.
The First installment will be disbursed with a written application for grant with SVIEC letter
to Director Research Cell.
All communication related to grant utilization or withdrawal of installments shall route
through Director, Research Cell.
Any patent generated by research work under this scheme will be shared with Sumandeep
Vidyapeeth.
In all publications, it is mandatory to include the name of Sumandeep Vidyapeeth.
Department of Pharmacy 2012
5 Compendium of Research
Ongoing research projects
Industry sponsored research projects
Sr. No. Name of the project Industry name Funds
received (Rs)
1 Effect of Normacid syrup and
powder in experimentally
induced peptic ulcer in mice
Ayur Lab, Halol 18,000/-
2 Effect of Dibolin PHF in
experimentally induced type
2 diabetes in rats
Ayur Lab, Halol 10,000/-
3 In vivo evaluation of AHR – 1
(PHF) on anaphylaxis model
in rats
Ayur Lab, Halol 32,750/-
Department of Pharmacy 2012
6 Compendium of Research
PG Students research projects
Sr no Name of student Title of the project
1. Juned M gazi Formulation evaluation and opatimisation of beta cyclodextrine inclusion complex of aceclofenac
2. Mahesh C Rathi Development and characterization of nanoparticulate delivery system of quetiapine
3. Vishal N Raval Formulation evaluation of gastroretentive drug delivery of gliclazide
4. Anju Kanojiya Formulation, Evaluation and opatimization of self emulsifying grug delivery system an antifungal drug
5. Jayesh J Patel Design, development,Optimization and characterization of aceclofenac loaded ethosome for transdermal delivery
6. Aniket R Raval Formulation, Evaluation and opatimization of Mebendazole colon targeted sr pellets by extrusion spheronization
7. Milan S Patel Formulation evaluation and opatimization of dry suspension formulation of azithromycin
8. Hemil H Desai Formulation and evaluation of enteric coater pellets of esomeprazole compressed into delayed release tablets
9. Pratik Patel Formulation, developamet and evaluation of chlorhexidine gluconate gel for periodontitis
10. ketan D Patel Formulation and evaluation of atorvastatin nanosuspension for bioavailability improvement
11. Sonu D naik Process validation of loperamide HCI tablet
12. Hardik Shah Validation of water treatment system and heating ventilation and air conditioning system in Pharmaceutical industry
13. Dhaval N Darji Development and validation of stability indicting method for the assay and related substance of acipimox in bilk drug form by HPLC
14. Krishna R Patel Development and validation of RP- HPLC method for estimation
15. Ishwardan J. gadhvi HPLC Method development and validation for estimation of withaferin a in poly -herbal formulation
16. Kinnar P patel Development and validation of stability-indicating method for the assay and related substance of ceftriaxone in ceftriaxone for injection USP
17. Ankit Prajapati Analytical method development and validation of voglibose and metformin in combined dosage form
18. Krupa D Shah development and validation of paracetamol and tramadol in tablet dosage form by UV method and HPLC method
19. Prdip G Parikh Retrospective process validation of roseamine soft getatin capsule
Department of Pharmacy 2012
7 Compendium of Research
20. Maunang M Patel Analytical method development and validation of lawsone in polyherbal formulation by HPC
21. Vimaldas Patel Enhancement of dissolution profile o f lornoxicam tablets by improving its solubility by various techniques
22. Imran Umatiya Formulation and evaluation of solid lipid nanoparticles of isoniazid
23. Mr Ankit Patel Development and characterization of new natural polymer for the formulation of sustained release oral dosage form
24. Juhi D Patel Design,development and characterization of ph sensitive hydrogel for intestinal delivery of prednisolone
25. Hiren Patel Formulation and evaluation of nanoemulasion of ketoconazole for topical delivery
26. Devendra Sharma Preparation and evaluation of aceclofenac topical microemulsion gel
27. Sunny Shah Design, development, opatimization and charaterization of immediate release tadalafil tablet
28. Chirag S Patel Preparation and in -vitro characterization of methotrexate loaded nano suspension
29. Jaymin N Desai New analytyical method development and validation od cefixime and linezolid in tablet dosage form
30. Chirag M Patel Analytical method development and validation of cefixime and azithromycin in combined dosage form
31. Viral Shah Development and validation of cetypyridinium chloride and benzocaine by Rp-HPLC method
32. Mukesh Rathi New analytical method development and validation of tramadol hydrochloride and dicyclomine hydrochloride in tablet dosage form
33. Sujit Kumar Sharma New analytical method development and validation of tolperison hydrochloride and diclofenac sodium in dosage form
34. Snehak K Tank New analytical Method development and validation of tolperisone hydrochloride and lornoxicam in tablet dosage form
35. Vivak Dhola Effect of tank wood seed alone and combinition with vitamine and lycopic acid on ethylene glycol and vitamin D3 induce urolithiasis in rat
36. Barvaliya Nitesh Effect of curcumin and several antioxidenta on doxorubicin induced cardiotoxicity in rat
37. Shivam S Jani In vivo evaluation of PHF on anaphylaxis model on rats and G. pig
38. Priydutt S Bhatt New analytyical method development and validation od cefixime and linezolid in tablet dosage form
39. Manoj R Patel Analytical method development and validation of cefixime and azithromycin in combined dosage form
Department of Pharmacy 2012
8 Compendium of Research
40. Jaymin D Patel Formulation and characterization of nanosuspension of an anti- viral drug
41. Ghanshyam V Patel Design, Formulation and characrerization of cyclosporine loaded colon targeted microspheres for the treatment of rheumatoid arthritis
42. Manan Shah Design, development and Optimization of sustain release metoclopramide microsphere
43. Gandhi Kevin S Formulation and evaluation of carbamazepine extended release tablets
44. Ashwin Patel Losartan potassium loaded transdermal patch: Design and I vitro characterization
45. Sachin R Patel Formulation, opatimazation and evaluation of gastro retentive controlled release floating microspheres of venlafaxine HCL
46. Kashyap Patel Design evaluation of controlled release floating microspheres for better management hypertension
Department of Pharmacy 2012
9 Compendium of Research
Faculty research projects
1. Dr. Rajesh Maheshwari
Effects of coenzyme Q10 with antidiabetic and antihyperlipidemic drugs in experimental induced diabetic complication.
2. Dr. Ujjwal Sahoo
Design synthesis and pharmacological evaluation of novel oxadiazole, triazole and thiazolidinone-4-one
3. Mr. Sachin Chauhan
Design development optimization and evaluation of nanoparticulate drug delivery system of some anticancer drug.
4. Mr. Nirmal Shah
Techniques to improve bioavailability of Selective Estrogen Receptor modulators (SERMs) for treatment of osteoporosis
5. Mr. Ashim Kumar Sen
Development and validation of new analytical methods of some group of pharmaceuticals from its bulk and pharmaceutical dosage form
6. Mrs. Dhanya Sen
Development and validation of new analytical methods of some antihypertensive and antidiabetic group of pharmaceuticals from its bulk and pharmaceutical dosage form
7. Mr. Girish Sailor
Design development optimization and evaluation of novel drug delivery system of some phytopharmaceuticals.
8. Mrs. Falguni B Tandel
Analytical method development and pharmacokinetic study of some new anti-inflammatory agents
9. Mr. Ankur Javia
Design, development and characterization of colon cancer targeting folic acid conjugated Capecitabine nanoparticles
10. Mr. Chintan Aundhia
Formulation design and development of nano carrier system for treatment of osteoporosis
11. Mr. Ghanshyam Parmar
Pharmacognostic and pharmacological standardization of some Euphorbias plants.
12. Mrs. Aarti Zanwar
Analytical method development and validation of some drugs combinations.
Department of Pharmacy 2012
10 Compendium of Research
Completed research projects
PG Students research projects
Sr no Name of student Title of the project
1. Ronak Patel Formulation & evaluation of sublingual dosage forms of prazocin HCL
2. Kirtida Patel Formulation & evaluation of Ralonazine HCL microsphere
3. Jaymin Patel Formulation & evaluation of Methotrexate loaded nanoparticles
4. Chainesh Shah Formulation & evaluation Gastroretentive Floating microsphere of atorvastatin
5. Patel Lav Formulation & evaluation of Imidiate release tablet of Antihistaminic drug
6. Savaliya Jitendra Formulation & evalution of floating matrix tablet of atenolol.
7. Pathak Prashant Formulation & evalution characterization & invitro evaluation of aceclofenac solid dispersion in crporated gels
8. Bhagat Chintan Bioavailability improvement of Candensatron by various technique for treatment of Hypertension
9. Dhamat Khushal Dissolution enhancement of poorly soluble Aceclofenac by complexing with B- cyclodextrin
10. Bhalala Chirag Formulation & development of Bilayer tablet of Metformin HCL & Pioglitazone HCL
11. Shah Zeel Formulation & development of modifide solid oral dosage form for the treatment of cardiovascular disorder`
12. Vagada Rajnikant Formulation & evaluation of Novel gum based drug delivery system of Antiemetic
13. Pranay B. Patel
Development and validation of stability indicating method for the determination of assay and chromatographic purity of Cefepime for injection USP in bulk drug and pharmaceutical dosage form by RP - HPLC
14. Chauhan Urvashi Quantitative determination of Minocycline HCL & Zolpidem tartarate in pharmaceutical formulation
15. Patel Dhara Development & method validation of stability indicating RPHLC method for piperacillin tazobaclum PSU
16. Radadiya Rasik J. Analytical method development for estimation of Ranolazine & Eszopiclone in bulk & tablets
17. Vaghasiya Abhay Process validation of ciprofloxacin hydrochloride tablet
18. Parmar Purvi Process validation of artemether & lumefantrine tablet 80/ 480mg.
19. Sudani Tushar Development & validation of assay method for Silodosin by Rp-HPLC method in pure and marketed formulation
Department of Pharmacy 2012
11 Compendium of Research
20. Joshi Maharshi New analytical method development and validation of Domperidone and Naproxen in pharmaceutical formulation
21. Joshi Harsh New analytical method development and validation of Rosuvastatin and Ezetimibe in tablet dosage form
22. Makvana Jigar R Development of anlytical method for estimation of EPL
23. Patel Anjal Effect of Rosuvastatin cabbage & normacid on experimental induced ulcer in mice
Department of Pharmacy 2012
12 Compendium of Research
Amin N, Khandhar A, Seth A. Development and validation of stability
indicating assay method for lornoxicam& tramadol in tablet dosage form by
rp-hplc. Pharma Science Monitor. 2012;3(2).
Abstract
A simple, selective, precise and stability indicating high-performance liquid
chromatographic (HPLC) method for determination of Lornoxicam & Tramadol HCl in
tablet dosage form was developed & validated. The chromatographic conditions comprised
a reverse-phase C18 column (Inertsil ODS 3V C-18, 250 x 4.6 mm, 5 μ with a mobile phase
consisting of a mixture of solution (5.7606 gm Ammonium dihydrogen phosphate in 2000
mL of milli-Q water, 7.3 pH adjusted with Tri ethylamine) & Acetonitrile in the ratio of
70:30, %v/v. The flow rate was kept 1.5 ml/min. and the detection was carried out at 230
nm. The retention times of Lornoxicam & Tramadol were 12.2 & 6.5 min. respectively. The
linear regression analysis data for calibration plots showed good linear relationship with
coefficient of correlation values, r = 0.999 for Lornoxicam& Tramadol HCl in the
concentration ranges of 0.16- 96 μg mL-1 & 0.2- 400 μg mL-1 respectively. LOD values
were found to be 0.16 & 0.2 μg/ml for Lorno&Trama respectively. LOQ values were found
to be 0.53 & 0.67 μg/ml for Lorno & Trama respectively. The method as validated for
precision, recovery, and robustness. The lornoxicam & tramadol HCl undergoes
degradation under acidic, basic, oxidative, photochemical, and thermal conditions.
Statistical analysis proves that the method is reproducible & selective for the estimation of
Lornoxicam& Tramadol HCl under study. As the method could effectively estimate the
vitamins in the presence of their degradation products, it can be employed as a stability
indicating method.
Keywords: Lornoxicam, Tramadol HCl, Validation, Stability indicating method
Department of Pharmacy 2012
13 Compendium of Research
Chirag P, Ujwal S, Seth A, Viral S, Umesh U. Formulation and evaluation of
solid dispersion of olanzepine. Pharma Science Monitor. 2012;3(3).
Abstract
The poor dissolution rate of water-insoluble drugs is still a major problem conforming the
pharmaceutical industry. Therefore, the enhancement of the dissolution rate of poorly
water-soluble drugs after oral administration is one of the most challenging aspects of
modern pharmaceutics. Olanzepine exhibits very slight solubility in water and as a
consequence it exhibit low bioavailability after oral administration. Therefore, the
improvement of olanzepine dissolution from its oral solid dosage forms is an important
issue for enhancing its bioavailability and therapeutic efficacy. The purpose of present
work is to improve the solubility of Olanzepine by preparing its dispersion with polymer
PEG(Poly Ethylene Glycol) using solvent evaporation technique.
Keywords: Olanzepine, Solvent Evaporation, Solid Dispersion, Solubility
Department of Pharmacy 2012
14 Compendium of Research
Desai D, Seth A, Molvi K, Mansuri M, Prajapati B. Synthesis and
antibacterial activity of nickel complex of some novel nitroimidazole. Pharma
Science Monitor. 2012;3(2).
Abstract
The Ni(II) complex of novel, 2-(1-(substituted)-5-nitro-1H-imidazol-2-yl)-1-(substituted)
ethanone have been synthesized and characterized by FTIR, molar conductivity, 1 HNMR,
MASS. Novel 2-nitroimidazole act as a bidentate ligand through the 3-N of imidazole ring
and C=O, at 2-position of nitroimidazole, which coordinate the metal ion give rise to 4-
coordinate tetrahedral Ni(II) complex. The in vitro antimicrobial activity was determined
by using cylinder plate method. The compounds were found to be more active than ligand
against Gram-positive bacteria, B. Pumilus ATCC 14884, S. aureus ATCC 29737 and Gram
negative bacteria, S. aboney NCTC 6017.
Keywords: nitroimidazole, complex, Nickel chloride, ligands.
Department of Pharmacy 2012
15 Compendium of Research
Desai J, Khatri N, Chauhan S, Seth A. Design, development and optimization
of self-microemulsifying drug delivery system of an anti-obesity drug. Journal
of pharmacy &bioallied sciences. 2012;4(Suppl 1):S21.
Abstract
The aim of the present work was to formulate a self-microemulsifying drug delivery system
(SMEDDS) containing orlistat. The oil, surfactant, and co-surfactant were decided based on
the solubility studies. Pseudoternary phase diagrams were plotted, microemulsification
area was determined and different formulations were prepared. Particle size, zeta
potential, dispersibility test and thermodynamic stability studies were measured. In-vitro
dissolution test of thermodynamically stable formulations OS-B and OS-C were carried and
results were compared with those of plain drug and suspension formulation. Stability
studies performed indicated that formulation OS-C remained stable over 12 months period.
Thus this investigation concluded that hydrophobic drugs like orlistat can be delivered
effectively through the formulation of SMEDDS.
Keywords: Dissolution; Orlistat; phase diagram; thermodynamic stability
Department of Pharmacy 2012
16 Compendium of Research
Donga J, Surani V, Chauhan S, Aundhia C, Seth A.Formulation, and in-vitro
evalution of sustained release tablet of nifidipine using hydrophilic polymer.
Pharma Science Monitor. 2012;3(4).
Abstract
Conventional drug delivery system for treating the angina and hypertension are not much
effective as the drug do not reach the site of action in appropriate concentration. Thus an
effective and safe therapy of this angina and hypertension disorder using specific drug
delivery system is a challenging task to the pharmaceutical technologists. Most commonly
used method of modulating the drug release is to include it in a matrix system because of
their flexibility, hydrophilic polymer matrix systems are widely used in oral controlled
drug delivery to obtain a desirable drug release profile, cost-effectiveness, and broad
regulatory acceptance. Formulation of Nifedipine sustained release tablet was prepared by
the polymers blend with to get desirable release profile. Formulated tablets were also
characterized by parameters like thickness, weight variation test, drug content uniformity,
hardness, friability and the in-vitro drug release rate profile was compared with the
marketed product release profile with the help of similarity factor (f2) and difference value
(f1). Formulation prepared with HPMC K100M indicates 97.20% of drug release at 12 hrs
and it has similarity factor (f2) value 96.97 and difference factor (f1) value 0.59.
Hydrophilic polymer HPMC K100M showed 12 hrs release of Nifedipine drug.
Keywords: Nifedipine, HPMC K100M, Sustained release, Matrix tablets.
Department of Pharmacy 2012
17 Compendium of Research
Gurjar NM, Seth A, Zanwar A, Patel J, Deshmukh G. Development of first
derivative spectroscopy method for estimation of budesonide and formeterol
in combined dosage form. Pharma Science Monitor. 2012;3(1).
Abstract
Sensitive, precise, accurate, and simple UV spectrophotometric methods have been
developed for simultaneous estimation of Budesonide (BUD) and Formeterol (FRL) in dry
powder inhaler dosage form. The method employed first order derivative spectroscopy in
which derivative amplitudes were measured at selected wavelengths (269.4 nm for BUD
and 284.6 nm for FRL). Linearity was observed in the concentration range of 2-26 µg/ml
for BUD and 10-100 mcg/ml for FRL. The method was found to be accurate (mean
percentage accuracy 100.07 )for budesonide and (mean percentage accuracy 100.06) for
formeterol and precise with %RSD 0.41 and 0.96 for BUD and FRL(API) respectively(for
intraday) and % RSD 0.42 and 0.84 for BUD and FRL (combined dosage form) respectively
(for intraday) and 0.78 and 0.48 for BUD and FRL (API) respectively (for inter-day) and
0.61 and 0.45 for BUD and FRL (combined dosage form) respectively (for interday). The
proposed methods have been applied successfully to the analysis of cited drugs in
pharmaceutical formulations. The methods were validated as per ICH guidelines.
Keywords: Budesonide, Formeterol, first order derivative spectroscopy.
Department of Pharmacy 2012
18 Compendium of Research
Kumar P, Yadav AS, Kumar S, Yadav YC, Seth A, Jha V. Process validation of
pantoprazole sodium delayed release tablet usp 40 mg. Inventi Impact:
Pharmaceutical Process Development. 2012.
Abstract
In present work, concurrent process validation of Pantoprazole Sodium 40 mg delayed
release tablets was carried out to monitor process parameters in current production
batches. The process validation was divided into two major steps, first one is process
validation of dosage form before coating, and second one is after coating. In-process quality
monitoring of all critical processing steps was done for three production batches, before
coating and after coating. End product testing of current production batches was done to
provide documented evidence that manufacturing process is in state of control. Assay for
drug content was within the limit of 100%-104% at the dry mixing stage. LOD for the dried
granules after wet granulation was within 1-4% RSD. Assay after lubrication was within the
specified limit at different corners in the blender, indicating blend uniformity. Physical
parameters like average weight of core tablet was found to be 180.95%-182.25%,
thickness was found to be between 3.25 cm-3.60 cm, hardness was found to be
5.08kg/cm2-5.65kg/cm2, %friability was between 0.117%-0.134%. disintegration time
was 181sec -202 sec, assay of core tablets 99.54%-100.13 % for all the three batches of
compressed tablets. Two coatings were applied on the core tablets, base coating and
enteric coating. Base coating using OPADRY polymer and enteric coating using ACRYL EZE
polymer. Temperature monitoring was done throughout the coating process. After coating
percentage weight build up was within 10%-12%. Finished product assay was between
99.56%-100.23%. No dissolution of active occurred in acidic medium up to 2 hours, drug
release in buffered medium was within the limit of 96%-100% within 30 min. Average
weight of coated tablet was between 200.52mg-202.37mg. Diameter of coated tablets was
9.1mm- 9.19mm. Thickness was 3.97cm-3.99 cm. Uniformity of dosage forms for 10 dosage
unit is between 98.91%- 99.05%, which is within the acceptance limit of = 15 %. Blister
strip packing was carried out for the tablets. During packing operation each pack size was
checked for physical appearance and sealing quality and found satisfactory. All the tests
Department of Pharmacy 2012
19 Compendium of Research
were found to have satisfactory results. Thus process validation of pantoprazole tablets
was successfully completed and found within the specifications.
Department of Pharmacy 2012
20 Compendium of Research
Malik A, Kushnoor A, Saini V, Singhal S, Kumar S, Chand Yadav Y.
Analytical method development of nutraceutical: umbelliferone. Pharma
Science Monitor. 2012;3(1).
Abstract
Coumarins, an old class of compounds, are naturally occurring benzopyrene derivatives. A
lot of coumarins have been identified from natural sources, especially green plants.
Coumarins have attracted intense interest in recent years because of their diverse
pharmacological properties. Phytochemical investigation on the fruit of Aeglemarmelos
(Rutaceae) has resulted in the development of analytical method for Umbelliferone. The
present study was undertaken to develop a validated, rapid, simple, and low-cost
ultraviolet (UV) spectrophotometric method for estimating Umbelliferone in dosage
preparations. UV spectrophotometric analysis was performed spectrophotometrically at a
pre-determined λ_max of 324 nm with distilled water (using ethanol as co-solvent) as
diluent/blank. The method was validated for linearity, accuracy, precision, reproducibility,
and specificity as per International Conference on Harmonization (ICH) guidelines. The
method was also used in the determination of the content of umbelliferone in formulations
of umbelliferone. The regression data for the calibration plots exhibited good linear
relationship (R² = 0.9991) over a concentration range of 0.5– 6.5 μg/ml and the linear
Regression equation was y=0.169 x + 0.023. Mean recovery accuracy was 96.9 %, which
was not significantly different from the expected value (p = 0.05), while coefficient of
variation (CV) for both intra-day and inter-day was < 7 %. The method was specific for
umbelliferone in the presence of common excipients, and when it was applied to
formulations, umbelliferone content was 97.89 ± 3.08 and 99.05 ± 1.99 %, respectively, of
calculated claim. The proposed method gave good validation results and the statistical
analysis performed proved that the method is precise, accurate, and reproducible, and
hence can be employed for routine analysis of umbelliferone in bulk and commercial
formulations.
Keywords: Umbelliferone, Spectrophotometric method, Validation, Dosageformulations,
Quality control.
Department of Pharmacy 2012
21 Compendium of Research
Mansuri M, Seth A, Molvi K, Prajapati B, Desai D. Synthesis and
pharmacological evaluation of some 3-(4-(substituted) 2-morpholino-4-yl-4-
phenyl-thiazole-5-carbonyl)-1-benzopyran-2-one. Pharma Science Monitor.
2012;3(2).
ABSTRACT
Taking in to consideration of diverse biological activities of coumarin and thiazole
derivatives, attempts have been made to attach a thiazole side chain at C-3 position of
coumarin. In addition, to expand the structural diversity of synthetic courmarins for
biological functions, the morpholine fusion at 2nd position of thiazole was also attempted.
The compounds MM3M1 were synthesized keeping coumarin-3-yl constant at fifth
position, morpholine at 2nd position and phenyl moiety at 4th position of thiazole nucleus.
The compounds MM3M2, MM3M3 and MM3M4 were synthesized keeping coumarin-3- yl
constant at fifth position, morpholine at 2nd position and introducing electron
withdrawing group (-Cl) at ortho, meta and para position respectively in phenyl moiety at
4th position of thiazole nucleus. All the synthesized compounds were evaluated for their
invitro antibacterial and anti-platelet activity. On the basis of structure-activity relationship
studies of synthesized MM3M1- MM3M4 it can be concluded that presence of 2-
chlorophenyl group at the 4th position of the thiazole contributes significantly to
antibacterial and anti-platelet activity profile of the candidates.
Keywords: Coumarin, thiazole, antibacterial activity, anti-platelet activity.
Department of Pharmacy 2012
22 Compendium of Research
NathYadav S, Zanwar A, Katewa J, Seth A. Process validation of paracetamol
tablet.Pharma Science Monitor. 2012;3(3).
Abstract
In present work, concurrent process validation of Paracetamol Tablet 500 mg, good release
tablets was carried out to monitor process parameters in current production batches. In-
process quality monitoring of all critical processing steps was done for three production
batches, End product testing of current production batches was done to provide
documented evidence that manufacturing process is in state of control. Assay for drug
content was within the limit of 98%-102% at the dry mixing stage. LOD for the dried
granules after wet granulation was within 1.30-1.80%. Assay after lubrication was within
the specified limit at different corners in the blender, indicating blend uniformity. Physical
parameters like average weight of tablet was found to be 589.5mg-592.5mg, thickness was
found to be between 4.0mm-4.4mm, hardness was found to be 3.0kg/cm2 - 5.0kg/cm2 ,
%friability was between 0.25%-0.41%. Disintegration time was 3min -4min, assay of
tablets 99.4%-100.0 % for all the three batches of compressed tablets. Temperature
monitoring was done throughout the process. Dissolution occurred in buffer up to 30 min.
at-50 rpm. , drug release in buffered medium was within the limit of 95%- 98% within 30
min. Thickness was 4.09mm-4.24 mm. Uniformity of dosage forms which is found to be (98
% to 102%). Blister strip packing was carried out for the tablets. During packing operation
each pack size was checked for physical appearance and sealing quality and found
satisfactory. All the tests were found to have satisfactory results. Thus process validation of
paracetamol tablet 500mg was successfully completed and found within the specifications.
Keywords: Paracetamol Starch, Pyrolidone cellulose Magnesium Stearate & Talcum having
Good Release property, Process validation, Concurrent validation
Department of Pharmacy 2012
23 Compendium of Research
Patel KM, Zanwar A, Kumar Sen A, Sahoo U, Seth A. Simultaneous
estimation of levofloxacin hemihydrate and ornidazole in tablet dosage form
by using simultaneous equations method. Pharma Science Monitor. 2012;3(1).
Abstract
The simple, accurate, precise, reproducible and economical procedure for simultaneous
estimation of Levofloxacin hemihydrate and Ornidazole in tablet dosage form as well as in
bulk drugs have been developed using double beam UV Spectrophotometer. The method
based on solving of simultaneous equation using 289 nm (λmax of LEV) and 320 nm (λmax
of ORN) as two analytical wavelengths for both drugs. The solution of both drugs was
prepared using Distilled water as a solvent. The proposed method is suitable for
simultaneous determination of Levofloxacin hemihydrate and Ornidazolein pharmaceutical
dosage form.
Keywords: levofloxacin hemihydrate, ornidazole, Simultaneous equation method.
Department of Pharmacy 2012
24 Compendium of Research
Patel Y, Sen A, Shah B, Seth A. Development and validation of new analytical
method for quantitative estimation of racecadotril as an active phamaceutical
ingredient by rp-hplc. Pharma Science Monitor. 2012;3(4).
Abstract
A simple and sensitive spectroscopic method was developed for the estimation of
Racecadotril in pharmaceutical dosage forms. Spectroscopic method is showing absorbance
at 231 nm in methanol. This method obeys Beers law in the concentration range of 8 to100
μg mL-1 respectively. The proposed method is precise, accurate and reproducible and can
be extended to the analysis of Racecadotril in bulk and tablet formulations. The
quantitative determination of the drug was carried out using the second-derivative values
measured at 223, 250 and 273 nm and Third-derivative spectrum values measured at
226and 240nm.Calibration graphs constructed at these wavelengths were linear in the
concentration range of 8-100µg mL-1 for secondderivative and third-derivative
spectrophotometry method. A HPLC assay utilized Phenomenex-Luna RP-18(2)
(250X4.6mm, 5 mm) column, with mobile phase composition of Acetonitrile: 0.05M
phosphate buffer (Potassium dihydrogen orthophosphate): triethylamine [80:19.95:0.05,
(v/v/v)] of pH 3.953 ± 0.2 was used, and flow rate was 1.0 ml min-1 with UV detection at
231 nm. Atorvastatin calciumvastatin calcium (ATOR) was used as internal standard. The
retention time of Racecadotril and ATORVASTATIN CALCIUM were 4.22 and 3.453 min
respectively. The total HPLC run time was less than 6 min. Linearity was observed over
concentration range of 8-80 µg ml-1 for Racecadotril. The proposed method was validated
for various ICH parameters like linearity, limit of detection, accuracy, precision,
ruggedness, robustness, and system suitability.
Keywords: Racecadotril, Validation, RP-HPLC method.
Department of Pharmacy 2012
25 Compendium of Research
Prajapati B, Seth A, Molvi K, Mansuri M, Desai D. Synthesis of some novel 2-
substituted nitroimidazole as potent anti-anaerobic agent. Pharma Science
Monitor. 2012;3(2).
Abstract
The nitroheterocyclic compounds have proved to be very effective antimicrobial agents
and very valuable member of limited armamentarium of antiprotozoal agents. A number of
5-nitoimidazole with substitution at 2-position with various substitutent are found to
modify the antibacterial spectrum. Some 2-substituted nitroimidazole analogues were
designed, synthesized and characterized. The synthesized compounds were tested for their
antibacterial sensitivity against Gram-positive anaerobe (C. sporogenus) and Gramnegative
anaerobe (B.fragilis) using macro broth dilution method. All the synthesized compounds
exhibit good activity at 10 mcg/ml against Gram-negative anaerobe compared to standard
control tinidazole and metronidazole, while remain inactive against Gram-positive
anaerobe.
Keywords: nitroimidazole, reduction, acid chloride, macro broth dilution.
Department of Pharmacy 2012
26 Compendium of Research
Prajapati B, Seth A, Molvi K, Rathod I, Suhagia B, Mansuri M, et al.
Extended huckel partial atomic charges of nitroimidazole and prediction of
dna damage. Pharma Science Monitor. 2012;3(2).
Abstract
Nine nitroimidazoles drugs representing different class were found in the literature to have
their respective half wave potential and one electron reduction potential measure under
near-identical conditions. The structures of these nine nitroimidazoles were optimized, and
resulting physicochemical parameters were regressed against one electron reduction
potential (OERPs). A very significant linear correlation (QSAR) was found between OERPs
and Extended Huckel Partial Atomic Charges. These findings suggest that it may be possible
to estimate OERPs of nitroimidazole in advance to its synthesis. Insofar as the OERPs
correlating to DNA damage, radiosensitization efficiency, aerobic cytotoxicity, mutagenicity
and hypoxic cytotoxicity; the Extended Huckel Partial Atomic Charges can predict well all
these biological activity prior to synthesis of novel nitroimidazoles.
Keywords: One electron reduction potential, nitroimidazole, partial charge, half wave
potential.
Department of Pharmacy 2012
27 Compendium of Research
Shrey S, Ghelani T, Shah N, Seth A, Deshmukh G, Chauhan S, et al.
Formulation and in vitro evalution of sustained release tablets of
clomipramine hydrochloride. Pharma Science Monitor. 2012;3(1).
Abstract
Current state of art is witnessing a revolution in new techniques for drug delivery.
Nevertheless, convenience of manufacturing and patient compliance has maintained their
significant importance in the design of drug delivery systems. The objective of the project
was to develop a stable and robust formulation of the clomipramine hydrochloride. The
present study deals with evaluation and optimization of various critical formulation and
process variables of oral solid sustained release dosage form, containing an antidepressant
clomipramine hydrochloride drug. Clomipramine was having extensive 1st pass
metabolism and associated with frequent dosing of conventional dosage form makes it a
suitable candidate for sustained release dosage form for patient compliance. For present
work, eudragit having different grades like RL 30D, RS 30D were selected as release
retarding agent. Matrix system of clomipramine hydrochloride based on hydrophobic
polymer (eudragit RL 30D, eudragit RS 30D, etc.) was tried individually as well as in
combinations. Finally core tablets were coated using HPMC 6 Cps. Final optimized batches
(F011) obtained fulfilled the criteria of significantly retard the release up to 24 hours with
initial loading dose release. Thus it was considered as the optimized batch for once a day
sustained release tablet formulation containing clomipramine hydrochloride.
Keywords: Clomipramine hydrochloride, eudragit RL 30D, eudragit RS 30D, HPMC 6Cps,
sustained release tablets.
Department of Pharmacy 2012
28 Compendium of Research
Surani VS, Donga JJ, Chauhan S, Ghelani T, Seth A, Shah N, et al. Design,
development and evaluation of the hydrodynamically balanced tablets of
ciprofloxacin hydrochloride. Pharma Science Monitor. 2012;3(1).
Abstract
Ciprofloxacin HCl has an absorption window in the stomach and in the upper part of the
small intestine. The present investigation concerns the development of hydrodynamically
balanced tablets of ciprofloxacin, which are designed to prolong the gastric residence time
and thereby increase drug bioavailability after oral administration. Five different batches of
tablets were fabricated containing Ciprofloxacin, polymers like HPMC K4M, HPMC K15M
and Chitosan, along with gas generating agent sodium bicarbonate. The physicochemical
properties of different formulations, their buoyancy lag time, total floatation time and
swelling index were evaluated. It was found that the hardness of the tablet will affect the
buoyancy characteristic of the dosage form. The in vitro release studies (USP XXIII)
indicated that the floating dosage forms containing HPMC K15M showed slower release
and the integrity of the device was maintained. The % drug release profile was found in the
order of F2 > F3 > F6 > F1 > F5 > F4. The in vitro release data was treated with
mathematical equations, and it was concluded that release of ciprofloxacin from the tablet
follows Peppas model with non-Fickian diffusion. F2 formulation showed better control of
drug release with comparison to marketed product. Finally the results had proven that the
gas powered Hydrodynamically Balanced Tablets of ciprofloxacin containing HPMC K15M
provides a better option for controlled release action and improved bioavailability.
Keywords: Gastric residence; Gas generation; Swelling index; Ciprofloxacin.
Department of Pharmacy 2012
29 Compendium of Research
Tank P, Zanwar A, Seth A, Kumar S. Development of new analytical methods
for quantitative estimation of racecadotril as an active pharmaceutical
ingredien by uv spectrophotometer. International Journal of Pharmaceutical
Sciences and Research. 2012;3(5):1495.
Abstract
A simple and sensitive spectroscopic method was developed for the estimation of
Racecadotril in pharmaceutical dosage forms. This method is based on Racecadotril,
showing absorbance at 231 nm in methanol. This method obeys Beers law in the
concentration range of 8 to 100 µg mL-1 respectively. The proposed method is precise,
accurate and reproducible and can be extended to the analysis of Racecadotril in bulk and
tablet formulations. The method was linear (r=0.9998) at concentrations ranging from 8 to
100 µg ml-1, precise (repeatability and intermediated precision), exact (method of
standard addition), and Limit of detection µg ml-1 (0.088749). Limit of quantification µg
ml-1 (0.268938) was found and the % recovery is found 99.69%.
Keywords: Racecadotril, Validation, UV spectrophotometer method.