Abstract

REVIEW: DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD

Gupta Lavisha*, Kamble Priyadarshini and Pujari Pradeep

ABSTRACT

The number of drugs introduced to the market increases every year. These drugs can be either new entities or partial structural changes to an existing one. Very often there is a delay between the launch of the drug and its inclusion in the pharmacopoeia. This is due to possible uncertainty in the continued and wider use of these drugs, new toxic effects (due to withdrawal from the market), the development of patient resistance and the introduction of better drugs by competitors. Under these circumstances, standards and analytical procedures for these drugs may not be available in the pharmacopoeia. Therefore, it is necessary to develop new analytical methods for such drugs. Methodological development is a broad term. In both quantitative and qualitative analysis, it is necessary to develop a new method to estimate the amount of a substance or to verify the presence of a necessary component. The development and validation of analytical methods are central to drug discovery, development and production. Several drugs came to market every year; therefore, it is mandatory to develop new analytical methods for such drugs. After development, the new analytical method must be validated. Method development is the process of demonstrating that an analytical method is acceptable for use. Analytical method validation provides information on various steps and parameters such as accuracy, precision, linearity, limit of detection, limit of quantification, specificity, range and reliability. Validation should be done according to regulations such as ICH guidelines. This article is written to provide an overview of the development and validation of analytical methods.[1,2]

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