Development and Validation of Five Simple UV-Spectrophotometry Methods for Estimation of Anagliptin in Bulk and in-house Tablets

Abstract

Anagliptin is a Dipeptidyl peptidase-4 (DPP-4) inhibitor used in the treatment of diabetes. Five simple, specific, sensitive, rapid and economical UV- Spectrophotometry methods have been established for the determination of Anagliptin in bulk and in-house tablets. All five methods of UVSpectrophotometry based upon Zero Order, First Order and Second Order derivative Spectrophotometry have been established considering amplitude and Area under Curve of the spectrum. In all five methods, Anagliptin obeyed linearity in the concentration range of 2-8 μg/mL with correlation coefficient (r2>0.999). The % amount of drug estimated in the developed methods was found to be good agreement with label claimed in in-house tablet formulation. All the methods were validated as per International conference on Harmonization (ICH) guidelines. All these proposed methods were proved to be linear, accurate, precise and rugged and also adequately sensitive. Key words: Anagliptin, UV-spectro photometry, Area Under Curve technique, Derivative Spectro photometry, Validation.