Dr. Nitish Sharma, Ph.D.
Assistant Professor , Department of Pharmaceutical Analysis
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National Institute of Pharmaceutical Education and Research-Ahmedabad -
nitish[dot]sharma[at]niperahm[dot]ac[dot]in, nitish[dot]sharma[at]niperahm[dot]res[dot]in -
079-66745555 -
NIPER-Ahmedabad -
Gandhinagar
Research Interest
The primary research area includes Characterization of complex injectables and peptide formulations;
Analytical method development, validation using HPLC, UPLC, GC-MS/MS, LC-MS/MS, Particle Size analysis, In-Vitro release profile;
Impurity profiling, compatibility, Reverse Engineering, Particle size analysis, and stability analysis of pharmaceuticals;
Metabolomics profile of probiotic drink
Characterization of Exosomes
Drug product characterization
Extractable and Leachable study.
Drug-excipient interaction, genotoxic/mutagenic, nitrosamine impurity evaluation.
Characterization of analytes and impurity profiling.
Experience
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April 2021 -Present
Assistant Professor
NIPER Ahmedabad, Gujarat, India
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June 2013 - April 2021
Senior Manager
Analytical Research & Development in Sun Pharmaceutical Industries Limited (India)
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Feb 2006 - June 2013
Scientist
Analytical research- US-Europe market R&D, Dr. Reddys Laboratories Ltd, Hyderabad
Honours
1.) Dr. B.L Khurana memorial best publication award 2013 from Indian Pharmaceutical Association Mumbai.
Publications
1.) A novel and rapid validated stability-indicating UPLC method of related substances for dorzolamide hydrochloride and timolol maleate in ophthalmic dosage form
N Sharma, SS Rao, AM Reddy Journal of chromatographic science 50 (9), 745-755
2.) A validated ultra high-pressure liquid chromatography method for separation of candesartan cilexetil impurities and its degradents in drug product
KS Babu, NDA Kumar, U Gosada, N Sharma Pharmaceutical Methods 3 (1), 31-39
3.) Validated Stability-indicating High-performance Liquid Chromatographic Method for Estimation of Degradation Behaviour of Eberconazole Nitrate and Mometasone Furoate in Cream …
nitish sharma Indian Journal of Pharmaceutical Science 75 (1), 76-82
4.) A validated stability-indicating liquid-chromatographic method for ranitidine hydrochloride in liquid oral dosage form
N Sharma, S Singh RAO, PS REDDY, A MALLESWARA REDDY
Scientia Pharmaceutica 79 (2), 309-322
5.) LC and LC-HRMS studies on stability behavior of molnupiravir an anti-COVID 19 drug
S Jain, S Giri, N Sharma, RP Shah
Journal of Liquid Chromatography & Related Technologies 44 (15-16), 750-759
6.) A novel validated ultra-performance liquid chromatography Method for separation of eszopiclone impurities and its degradants in drug products
N Sharma, SS Rao, NDA Kumar, AM Reddy
Journal of AOAC International 96 (5), 981-986
7.) Optimization and validation of reverse phase liquid chromatographic method for estimation of Cetirizine mannitol ester impurity in Cetirizine hydrochloride chewable tablet
N Sharma, SS Rao, ND Atchuta Kumar, AM Reddy
Journal of liquid chromatography & related technologies 34 (18), 2157-2168
8.) Development and validation of a reverse phase-liquid chromatographic method for the estimation of butylated hydroxytoluene as antioxidant in paricalcitol hard gelatin capsule …
B Vaghela, SS Rao, N Sharma, P Balakrishna, AM Reddy
Pharmaceutical Methods 2 (4), 235-241
9.) LC-Q/TOF-HRMS and NMR based structural characterization of the major photodegradation impurity of difluprednate
N Sharma, S Giri, A Sahu, S More, P Sengupta, RP Shah
Chromatographia 85 (7), 605-615 1 2022
10.) A novel validated high pressure liquid chromatography method for separation of pioglitazone degradant in drug product
SS Rao, N Sharma, RA Malleswara
Int. J. Pharm. Pharm. Sci 4, 201-209
11.) A New Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) Method for Determination of Kinetin Riboside (Plant Hormone) in Dequalinium Chloride Based Self-assembled …
TG Agnihotri, D Badgujar, N Sharma, A Jain
Chromatographia, 1-13
12.) Modified NAP Test: A Simple and Responsive Nitrosating Methodology for Risk Evaluation of NDSRIs
N Sharma, R Patel, T Bothara, S Jain, RP Shah
Journal of Pharmaceutical Sciences
13.) Cutting-edge strategies and critical advancements in characterization and quantification of metabolites concerning translational metabolomics
MS Pillai, ST Paritala, RP Shah, N Sharma, P Sengupta
Drug Metabolism Reviews 54 (4), 401-426
14.) Synthetic pharmaceutical peptides characterization by chromatography principles and method development
N Sharma, D Kukreja, T Giri, S Kumar, RP Shah
Journal of Separation Science 45 (13), 2200-2216
15.) Recent Advances in Teriparatide Delivery by-virtue-of Novel Drug Delivery Approaches for the Management of Osteoporosis
S Salave, D Rana, S Shah, G Rawat, N Sharma, A Jindal, R Patel, …
Critical Reviews™ in Therapeutic Drug Carrier Systems
Research Scholars
Student Details
Sreeteja Paritala
Sreeteja is second year pH.D student.
Her research topic is Characterization of selected glycopeptide using advanced analytical approaches
Devendra Badgujar
Devendra is second year pH.D student.
His research topic is Characterization and Impurity Profiling of Synthetic
GLP-1 Analogues.
Deepkumar Maheshwari
Sachin Chaturvedi
Ashwini Chawathe
Expertise
Metabolomics profile of probiotic drink
Characterization of Exosomes
Drug product characterization
Extractable and Leachable study.
Drug-excipient interaction, genotoxic/mutagenic, nitrosamine impurity evaluation.
Characterization of analytes and impurity profiling.