Abstract

A GUIDE TO ANALYTICAL METHOD DEVELOPMENT AND VALIDATION IN HPLC: A REVIEW

Dr. Nutan Rao*, Madhusudan Bhoir, Akshata Desai and Shraddha Gaur

ABSTRACT

The number of drugs introduced into the market are increasing day by day every year. These drugs may be either new entities or structural modification of the existing drugs. The objective of any analytical development is to obtain reliable, consistent and accurate data. Validated analytical methods play a major vital role in achieving this goal. The results from method validation are used to determine the quality, reliability and consistency of analytical results. The analytical method development and method validation is an important process in the drug discovery. The drug which shows good potency, lack of validated analytical method will not allow the drug to enter into the market. This is to ensure the quality and safety of the drug. Analytical method development must be validated to provide reliable data for regulatory submissions. High Performance Liquid Chromatography (HPLC) was derived from the classical column chromatography and, is one of the most important tool in analytical chemistry. In the pharmaceutical industry, high performance liquid chromatography (HPLC) is the integral analytical tool applied in all stages of drug discovery, development and production. This review gives information about various stages involved in development and validation of HPLC method. It covers all the validation parameters, like specificity, accuracay, linearity and range, precision, limit of detection, limit of quantification, robustness and system suitability.

Keywords: HPLC, method development, validation.