A REVIEW ON METHOD DEVELOPMENT AND VALIDATION OF LC-MS/MS FOR ANALYZING POTENTIAL GENOTOXIC IMPURITIES IN GLIFLOZINS

The objective of this paper is to review the method development, optimize and validation of the method for the potential genotoxic impurities in gliflozins. The purpose of this validation is to show that processes involved in the development and manufacture of drug, production and analytical testing can be performed in an effective and reproducible manner. This review article provides guidance on how to perform validation characteristics for the analytical method which are utilized in pharmaceutical analysis.

Key words: Analytical method development, Genotoxic impurities, Pharmaceutical analysis, Validation