V3I1P45

RP-HPLC Method Development and Validation in Pharmaceutical Analysis: A Comprehensive Review

Rohan Nandkishor Mandve^1*

Abstract

High Performance Liquid Chromatography (HPLC), particularly Reverse Phase HPLC (RP-HPLC), is one of the most widely used analytical techniques in pharmaceutical research and quality control laboratories. The technique offers high sensitivity, accuracy, precision, and reproducibility, making it indispensable for drug discovery, development, and routine quality assurance. This review article presents a comprehensive overview of RP-HPLC principles, method development strategies, validation parameters as per International Council for Harmonisation (ICH) guidelines, and recent applications in pharmaceutical analysis. Emphasis is placed on critical factors affecting chromatographic performance, including mobile phase composition, stationary phase selection, detection systems, and robustness. The review also discusses recent advancements and challenges in RP-HPLC analysis. The article aims to serve as a useful reference for researchers, academicians, and quality control analysts involved in pharmaceutical analysis.

Keywords:

RP-HPLC, Method Development, Validation, Pharmaceutical Analysis, ICH Guidelines