Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF TENELIGLIPTIN AND METFORMIN BY USING RP HPLC

R. Vasanthi*, Nazia Begum, M. Alagar Raja, K. Rajeswar Dutt, K. N. V. Rao, H. Ramana and G. Koteshwar Rao

Abstract

A Rapid and Precise Reverse Phase High Performance Liquid Chromatographic method has been developed for the validated of Teneligliptin and Metformin, in its pure form as well as in tablet dosage form. Chromatography was carried out on X-Terra C18 (4.6 x 150mm, 5μm) column using a mixture of Methanol: TEA Buffer pH 4.5: Acetonitrile (65:15:20) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 243 nm. The retention time of the Teneligliptin and Metformin was 2.090, 5.289±0.02min respectively. The method produce linear responses in the concentration range of 5-25mg/ml of Teneligliptin and 45-225mg/ml of Metformin. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.

Keywords: Teneligliptin, Metformin, RP-HPLC, validation.