Abstract

UPDATED REVIEW ON ANALYTICAL METHOD DEVELOPMENT AND VALIDATION BY HPLC

Khushboo Pasbola* and Meenu Chaudhary

ABSTRACT

A review suggest systematic way for analytical method development for the separation of related substance or impurities from API and after development how we can perform a validation of that developed method as according to regulatory guidelines. Need of analytical method development in now days increases continuously due to number of alternative drug molecules are developing for customer satisfaction. Analytical technique as high performance liquid chromatography (HPLC) generally used to identify, separate, detect and quantities main active ingredient or API and its related substances. Method development is essential in case of discovery of drug molecule, drug development phase and in analysis of API and its related substances. Various prodrugs, Intermediates and organic impurities during product development phase do not have any pharmacopoeial method so we can develop the analytical method by own to set the specifications. The article focuses on HPLC method development, optimization of developed method and validation of developed analytical method as per ICH guideline Q2 (R1).

Keywords: HPLC, method development, related substances, validation, stability study.