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Abstract

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. INTRODUCTION:Most of the optimization of HPLC method development have been focused on the optimization of HPLC conditions. This article will look at this topic from other perspectives. Forced degradation or stress testing is undertaken to demonstrate specificity when developing stability-indicating methods, particularly when little information is available about potential degradation products. These studies also provide information about the degradation pathways and degradation products that could form during storage.