Dr. Nitish Sharma, Ph.D.
Assistant Professor , Department of Pharmaceutical Analysis
-
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 -
+91 79 65181200 -
NIPER-Ahmedabad -
Gandhinagar
Research Interest
- Characterization of complex injectables and peptide formulations including Impurity profiling and sameness with reference listed product;
- Analytical method development, validation using HPLC, UPLC, GC-MS/MS, LC-MS, Zetasizer, Size Exclusion Chromatography, SDS-PAGE, in-vitro dissolution Study;
- Impurities risk evaluation- Genotoxic, Nitrosamine, extractable/leachable study, residual solvent analysis, elemental impurities analysis;
- Pre formulation, reverse engineering, process analytical technologies
- Particle size determination and particle characterization for parenteral (nano suspensions by Malvern PSD, Zeta sizer and Morphologi G3.
Experience
- April 2021 to Present
Assistant Professor
Department of Pharmaceutical Analysis, NIPER-Ahmedabad National Institute of Pharmaceutical Education and Research (India)
- June 2013 to April 2021
Senior Research Manager (Group Leader)
Peptide Injectables, Analytical Research & Development in Sun Pharmaceutical Industries Limited (India).
- Feb 2006 to June 2013
Scientist
Analytical R&D, Dr. Reddy’s Laboratories Ltd, Hyderabad (India).
Research Grants
- As PI from Centre of Medical Devices NIPER-A (CMD/R AND D/01-25/P1/16)
- As CO-PI Investigator- Initiated Research Proposals for Small Extramural Grants (ICMR) (IIRPSG-2025-01-00637)
- As CO-PI Investigator- Initiated Research Proposals for Small Extramural Grants (ICMR) (IIRPSG-2025-01-00493)
- As PI from Sun pharmaceutical Industries Limited