Analytical Method Development and Validation by Reverse Phase - High Performance Liquid Chromatography: An Overview

Dipmala Ghorpade , Suhas Siddheshwar

RP-HPLC, Analytical, Validation, Mobile phase, ICH guidline

A simple, precise, accurate, specific and RP-HPLC method was developed for determination of drug in pharmaceutical formulation. Analytical method development and validation play important roles in the drug discovery, drug development and manufacture of pharmaceuticals. It involves detection of the purity and toxicity of a drug substance.The present study focuses on the various steps, parameters involved in HPLC condition.A number of chromatographic parameters were analyzed to optimize the method like sample pretreatment, choosing mobile phase, column, detector selection. Analytical method validation confirms the scientific firmness of measurement or characterization and is necessary throughout the regulatory submission process.Various validation parameters like accuracy, specificity, precision, linearity, LOD, LOQ, ruggedness, and robustness, System suitability also are listed concerning ICH Guidelines.

Published Paper   E-Certificate

"Analytical Method Development and Validation by Reverse Phase - High Performance Liquid Chromatography: An Overview", IJSDR - International Journal of Scientific Development and Research (www.IJSDR.org), ISSN:2455-2631, Vol.8, Issue 3, page no.1307 - 1311, March-2023, Available :https://ijsdr.org/papers/IJSDR2303213.pdf

Volume 8 Issue 3, March-2023

Pages : 1307 - 1311

Paper Reg. ID: IJSDR_204639

Published Paper Id: IJSDR2303213

Downloads: 000347211

Research Area: Pharmacy

Country: Ahmednagar, Maharashtra, India

Published Paper PDF: https://ijsdr.org/papers/IJSDR2303213

Published Paper URL: https://ijsdr.org/viewpaperforall?paper=IJSDR2303213

ISSN: 2455-2631 | IMPACT FACTOR: 9.15 Calculated By Google Scholar | ESTD YEAR: 2016

An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 9.15 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator

Publisher: IJSDR(IJ Publication) Janvi Wave

This work is licensed under a Creative Commons Attribution 4.0 International License and The Open Definition