Abstract

UV SPECTROSCOPY METHOD DEVELOPMENT AND VALIDATION FOR DETERMINATION OF VILDAGLIPTIN IN BULK AND FORMULATION

Afaque Ansari, Ravishankar Chadchankar*, Vaibhav Jadhav and Shivprasad Patil

ABSTRACT

The present study was undertaken to develop a spectrophotometric method for the determination of vildagliptin in pharmaceutical dosage forms. This paper describes a simple, rapid, accurate, and precise UV-spectrophotometric method for the assay of vildagliptin in bulk and marketed dosage forms. The validation of the developed method was carried out according to ICH guidelines concerning linearity, precision, accuracy, specificity, the limit of detection, and the limit of quantification. Calibration curves were obtained in the concentration range of 10-50 μg/ml for vildagliptin and with good correlation coefficients (R2=0.9995). The precisions of the new method for the drug were less than the maximum allowable limit (%RSD less than 2.0) specified by the ICH. Therefore, the method was found to be accurate, reproducible, and sensitive for analysis of vildagliptin in pharmaceutical dosage forms.

Keywords: UV spectroscopy, Method development, and Validation, Formulation, Vildagliptin.