Development and validation of rp-hplc method for the estimation of gemigliptin and metformin hydrochloride

RP-HPLC method has been developed for the estimation of Gemigliptin and Metformin Hydrochloride. The quantification was carried out Ci8 bonded phase i.e. Zorbax Eclipse XDB-C18 (4.6*250mm*5 µ) with particle size 5 µ/min an isocratic mode with mobile phase consisting of Methanol: Water (20:80% v/v). The detection was carried out using UV detector at 233 nm. The solutions of Gemigliptin and Metformin Hydrochloridewere chromatographed at a constant flow rate of 1 ml/min and the retention time of the drug was found to be 2.3 min and5.8 min respectively. The linearity range of Gemigliptin and Metformin Hydrochloride were found to be from 1- 35 µg/ml of Gemigliptin and 2–18 µg/ml of Metformin Hydrochloride. Linear regression coefficient for both drugs was 0.999. As per ICH guideline the method was validated for recovery, Precision, ruggednessand linearity.