Abstract

DEVELOPMENT AND VALIDATION OF AN UVSPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF TENELIGLIPTIN AND METFORMIN

Leena Ajay Sawaikar*

Abstract

Teneligliptin Hydrobromide is a recently developed oral dipeptidyl peptidase 4 inhibitor indicated for the management of type 2 diabetes mellitus (T2DM) in adults along with diet and exercise. It has a potent and a long lasting antidiabetic action. Metformin is a biguanide which also is an antidiabetic and works by improving the peripheral sensitivity to insulin. A combination of these two drugs produced a synergistic effect and better control of blood sugar. Literature survey reveals some methods of simultaneous estimation of these two drugs in combination which include HPLC LC-MS/MS, RP-HPLC and very few UV methods using organic solvents. In this work an attempt was made to develop a green, ecofriendly, simple UV spectrophotometric method based on simultaneous equation method for the simultaneous estimation of the drugs using water as diluent. The wavelengths chosen were 243 nm as λmax of Teneligliptin and 233 nm as λmax of Metformin. The Beer Lambert’s range for the two drugs was 5-50μg/mL, with correlation coefficient(r2) of 0.999. The method was found to be precise as %RSD for Interday and intraday precision of the method was< 2%. The method was accurate as % recovery at 80%, 100% and 120% was within acceptance limits. The developed method was applied to the analysis of a marketed formulation of the two drugs and the % assay results were within 90-110%. Hence, the developed method can be successfully used as a quality control tool for the routine analysis of the drugs in bulk and in combined dosage form.

Keywords: UV-visible spectrophotometer, Teneligliptin, Metformin.