STABILITY INDICATING HPLC METHOD DEVELOPMENT: A REVIEW

High performance liquid chromatography is one of the most accurate methods widely used for the quantitative as well as qualitative analysis of drug product and 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 manufacture of drug product. This article discusses the strategies and issues regarding the development of stability indicating HPLC system for drug substance. A number of key chromatographic factors were evaluated in order to optimize the detection of all potentially relevant degradants. The method should be carefully examined for its ability to distinguish the primary drug components from the impurities. New chemical entities and drug products must undergo forced degradation studies which would be helpful in developing and demonstrating the specificity of such stability indicating methods. At every stage of drug development practical recommendations are provided which will help to avoid failures.