Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR THE SIMULTANEOUS ESTIMATION OF VILDAGLIPTIN AND METFORMIN IN BULK DRUGS AND PHARMACEUTICAL DOSAGE FORM

Mayur T. Narkhede*, Sachin S. Rane, Rajesh Y. Chaudhari and Vijay R. Patil

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Abstract

A simple, robust, precise, UV spectroscopic method has been developed for the simultaneous estimation of vildagliptin and metformin in bulk and tablet dosage forms. In this paper the estimation of those drugs was carried out by simultaneous equation method.[1,2] This method is based on measurement of absorption at 268 nm and 235 nm i.e, λmax of vildagliptin and metformin respectively. The linearity observed for vildagliptin is in the range of 2-32μg/ml and for metformin is in the range of 10-50μg/ml. The accuracy of methods was assessed by recovery studies and was found to be within the range of 97.78%-99.86% for both vildagliptin and metformin.[2] The developed methods were validated with respect to linearity, accuracy (recovery), and precision. The method can be employed for estimation of pharmaceutical formulations with no interference from any other excipients and diluents. The results were validated as per ICH guidelines.[2,3]

Keywords: Vildagliptin, Metformin, ICH, Validation etc.