Abstract

A PRACTICAL APPROACH TO RP HPLC ANALYTICAL METHOD DEVELOPMENT

*Sunita Sule, Sushma Ambadekar, Deepak Nikam, Ameet Sule, Sudesh Bhure

Abstract

High performance liquid chromatography is one of the most widely used tools to identify and quantify potency in drug substances and drug products. Analytical method development and validation are two very critical processes performed before release of a method for use in Quality Control department. This article focuses on stepwise practical approach towards developing a RP HPLC assay method. The various contributing parameters and its effect on the performance of the RP HPLC analytical method being developed are described simply, such that a new chromatographer is able to develop a method with the understanding of the RP HPLC method development process and its parameters.

Keywords: Assay, Method development, Forced Degradation, Method Validation and High Performance Liquid Chromatography (HPLC).