HPLC method development and validation- an overview

Abstract

HPLC method development and validation play important role in the discovery, development and manufacture of pharmaceutical products. This article mainly focuses on the optimization of HPLC conditions and other important perspectives during method development and validation. Various critical steps related to analytical method development and validation is discussed. A sequence of events required for method development and analytical validation are described. The steps involved in developing a stability-indicating HPLC method influences the analysis of degradation products/impurities in stability study and its validation demonstrate the suitability for its intended purpose.