Development and Validation of Stability Indicating Methods by Chromatography: A Review

Abstract

High Performance Liquid Chromatography has become a powerful technique in analytical chemistry which evaluates drug product stability. This is most accurate method for quantitative and qualitative determination in the analysis of drug product. Forced degradation has a most crucial role in the development of stability indicating HPLC methods to separate various drug related impurities found during production or synthesis of drug product. This article will focus on strategies and areas of concern relevant to development of stability indicating methods by HPLC. Forced degradation studies provide us with degradation pathways of drug substances and products.