Development and Validation of an Analytical Method for the Estimation of Metformin and Teneligliptin in its Bulk and Tablet Dosage Form by using RP-HPLC

Teneligliptin in tablet dosage form, using Column Inertsil ODS column C8 (4.6 x 250mm), 5μm particle size, mobile phase Phosphate buffer (PH-3): Acetonitrile (50: 50) v/v, detection wavelength at 240nm, at flow rate of 1.0ml/min and the retention time 3.608 and 5.148 min. The correlation coefficient was found to be 0.999 for both the drugs. The Recovery studies were performed for Metformin and Teneligliptin in the range of 50%-150%. The % recovery of Metformin and Teneligliptin found to be 99.97 and 100.64 respectively. % RSD for Precision studies of Metformin and Teneligliptin was found to be 0.4 and 0.8. Forced Degradation studies were conducted according to the ICH guidelines and the Drug Product was found to be stable in all conditions. Hence we recommend that this method can be a good approach for the quantification of Metformin and Teneligliptin in combination dosage form and can be adopted for the routine quality control analysis of these drugs.