Abstract

A REVIEW ON ANALYTICAL METHOD VALIDATION

Chaudhari Payal Prakash*, Dr. Sunila. A. Patil and Dr. Sunil P. Pawar

ABSTRACT

Development and validation of analytical method play an essential role in the discovery, development and manufacturing of pharmaceuticals. Every year, number of drugs entered into the market; hence it is mandatory to develop newer analytical methods for such drugs. After the development, it becomes necessary to validate the new analytical method. Method development is the process which proves that the analytical method is acceptable for use. Validation of analytical method gives information about various stages and parameters like accuracy, precision, linearity, Limit Of Detection, Limit Of Quantification, specificity, range and robustness. Validation should be done as per regulatory guidelines such as ICH guidelines. This article was prepared with an aim to review analytical method development and validation. Regulatory authorities are placing greater emphasis on analytical methods in manufacturing. Drug approval by regulatory authorities requires the applicant to prove control of the entire process of drug development by using validated analytical methods.

Keywords: Analytical method, Spectroscopy, UV-VIS spectroscopy, Chromatography, HPLC Method, UHPLC Method, LC-MS Spectrometry. etc.