A Review on Method Development and Validation by Using HPLC

Abstract

Analytical method development and validation are the continuous and inter-dependent task associated with the research and development, quality control and quality assurance departments. High performance liquid chromatography (HPLC) has been widely used for years as an analytical method and is a key tool for the separation and analysis of pharmaceutical drugs, for drug monitoring and for quality assurance and life science research. Most of the drugs in multi component dosage forms can be analysed by HPLC method because of the several advantages like rapidity, specicity, accuracy, precision and ease of automation in this method. HPLC methods development and validation play important roles in new discovery, development, manufacture of pharmaceutical drugs and various other studies related to humans and animals. This review gives information regarding principle, types, instrumentation and along with various application of the method and Validation of HPLC method as per ICH Guidelines covers all the performance characteristics of validation, like Accuracy, precision, specicity, linearity, range and limit of detection, limit of quantication, robustness