Abstract

A COMPREHENSIVE STUDY OF ANALYTICAL METHOD DEVELOPMENT AND VALIDATION

Anshika Verma*, Jyoti Verma, Dr. Sanjay Kumar Kushwaha, Priya Patel

ABSTRACT

Pharmaceutical discovery, development, and manufacture depend heavily on the development and validation of analytical methods. As more medications are introduced to the market each year, it is necessary to create new analysis techniques for these medications. Following the development, the new analytical method needs to be validated. The process of demonstrating that an analytical method is suitable for usage is known as method development. Analytical method validation provides details on a number of phases and parameters, including accuracy, precision, linearity, limit of detection, limit of quantification, specificity, range, and robustness. Regulations like ICH rules should be followed when performing validation. This article was prepared with the intention of reviewing the development and validation ofanalytical methods.

Keywords: Analytical method, Spectroscopy, UV-VIS spectroscopy, Chromatography, HPLC, Method development, Validation.