Method development and validation using HPLC technique – A review

Abstract

Analytic method development and validation are key elements of any pharmaceutical development program. HPLC analysis method is developed to identify, quantity or purifying compounds of interest. 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.

Key Words: HPLC, method development, method validation.