Abstract

A REVIEW ON STABILITY INDICATING HPLC METHOD DEVELOPMENT

B. Varsha Rao*, G. Naga Sowjanya, A. Ajitha, V.Uma Maheshwara Rao

ABSTRACT

This article discusses strategies and issues pertinent to a review on Stability indicating HPLC method development. High performance liquid chromatography (HPLC) is an essential analytical tool in assessing drug product stability. HPLC methods should be able to separate, detect and quantify the various drug-related impurities that may be introduced during synthesis. It further understands the chemistry of the drug substance and drug product and facilitates the development of stability indicating analytical methodology. Various 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.

Keywords: HPLC, Forced degradation, stability indicating method.