Stability Indicating HPLC Method Development: A Review

High performance liquid chromatography is one of the most accurate method widely used for quantitative as well as qualitative analysis of drug product and it is used for determining drug product stability. Stability indicating HPLC methods are used to separate various drug related impurities that are formed during the synthesis or manufacturing of drug product. This article discusses the strategies and issues regarding the development of stability indicating HPLC system for drug substance. Keywords: stability indicating method, high performance liquid chromatography, drug substance.