European Journal of Biomedical and Pharmaceutical Sciences

STABILITY INDICATING ASSAY METHOD

Kolla Sandhya Rani, P. Krishna, N. Rachana Kumari, V. Manisree, B.V.P. Deepthi* and Dr. J.V.C. Sharma

ABSTRACT

The main contemporary goal of stability indicating methods is to provide information about condition for stress testing so as to establish the stability of drug substances and product. HPLC is one of the most accurate method widely used for qualitative as well as qualitative analysis of drug product and is used for determining drug product stability. High performance liquid chromatography (HPLC) is an integral analytical tool in assessing drug product stability. HPLC method should be able to separate detect, & quantify the various drug-related degradants that can form on storage or manufacturing, plus detect the quality of any drug-related impurities that may be introduced during synthesis. A number of key chromatographic factors, evaluated in order to optimize the detection of all potentially relevant degradants. The present review discusses the stability indicating assay methods(SIAM) and approaches for the development of SIAM as per the current regulatory requirements.

Keywords: RP-HPLC validation stability, Stability indicating method, Regulatory guidelines, degradation, Development of SIAMs, Stress testing.