Analytical Method Development and Validation for the Simultaneous Estimation of Metformine and Gemigliptin by RP-HPLC Method

Nair Ayana Ramesh¹, Dr. D. Naresh¹, Dr. Gampa Vijaya Kumar*^2
1KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
²Professor and Head, Department of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.

A B S T R A C T
The estimation of metformin and gemigliptin was done by RP-HPLC. The Phosphate buffer was p^H3.0 and the mobile phase was optimized with consists of Methanol: Phosphate buffer mixed in the ratio of 70:30 % v/ v. Inertsil ODS C₁₈ column   C18 (4.6 x 150mm, 5mm) .The detection was carried out using UV detector at 260 nm. The solutions were chromatographed at a constant flow rate of 0.8 ml/min. the linearity range of metformin and gemigliptin were found to be from 100-500 mg/ml of metformin and 1-5mg/ml of gemigliptin. Linear regression coefficient was not more than 0.999. The values of % RSD are less than 2% indicating accuracy and precision of the method. The percentage recovery varies from 98-102% of metformin and gemigliptin. LOD and LOQ were found to be within limit.
Keywords: Metformin, Gemigliptin, RP-HPLC