Abstract

A REVIEW ON ANALYTICAL METHOD DEVELOPMENT AND VALIDATION

V. Swetha*, Y. Pooja

Abstract

Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability and consistency of analytical results; it is an integral part of any good analytical practice. Describesthe analytical method development, optimization and validation and provide examples of successful method development and validation. In HPLC, the text presant an overview of FDA, ICH regulatory guidelines complian with validation requirements for regulatory agencies, and method validation criteria stipulated by the use pharmacopeia FDA and ICH. The analytical method validation is essential for analytical method development and tested extensively for specificity, linearity, accuracy, precision, range, detection limit, quantization limit, and robustness. Analytical method development and validation allows to confirm that an accurate and reliable potency measurement of a pharmaceutical preparation can be performed.

Keywords: Analytical method development and validation, guidlines, regulatory, accurate and reliable potency measurement.