Abstract

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

Khushabu R. Patil*, Dr. Tushar A. Deshmukh, Dr. Vijay R. Patil

ABSTRACT

A simple reverse phase liquid chromatographic method has been developed and subsequently validated for simultaneous determination of vildagliptin and metformin in combination. The separation was carried out using a mobile phase consisting of 2mM potassium phosphate buffer and Acetonitrile with pH 2.5 adjusted with ortho phosphoric acid in the ratio of 70: 30%v/v. The column used was Cosmosil C18, (150 mm x 4.6 mm i.d, 5μm) with flow rate of 1 ml / min using PDA detection at 227 nm. The described method was linear over a concentration range of 1-5 μg/ml and 10-50 μg/ml for the assay of Vildagliptin and Metformin respectively. The retention times of Vildagliptin and Metformin were found to be 2.08 and 6.50 min respectively. Results of analysis were validated statistically and by recovery studies. The limit of detection (LOD) and the limit of quantification (LOQ) for Vildagliptin and Metformin were found to be 0.0604, 0.1831 and 0.6802, 2.6821 respectively. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Vildagliptin and Metformin bulk drug and in its pharmaceutical dosage form.

Keywords: Vildagliptin, Metformin, RP-HPLC, Pharmaceutical dosage form.