Abstract

REVIEW ON METHOD DEVELOPMENT AND VALIDATION OF HPLC METHOD

Mayuri A. Patil*, Dr. S. T. Patil and Dr. S. P. Pawar

ABSTRACT

Validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose. Chromatographic methods play significant role in the pharmaceutical industry from the drug discovery, development, formulations and quality control. These methods are essential for a number of purposes, including testing for quality control release, testing of stability samples, testing of reference materials and to provide data to support specifications. A validated analytical method ensures that it provides consistent, reliable and accurate data. So these methods help pharmaceutical analyst to ensure quality products are released for market. This review describes general approach towards validation process and validation parameters to be considered during validation of a HPLC method. It also refers to various regulatory requirements. The parameters described here are according to ICH guidelines and include accuracy, precision, specificity and limit of detection, limit of quantitation, linearity, range and robustness.

Keywords: Method Development, Validation, HPLC.