ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF TENELIGLIPTIN AND METFORMIN HCL BY RP-HPLC.

Separation of Teneligliptin and MetforminHcl was successfully achieved THERMO, C18, 250X4.6mm, 5µm,or equivalent in an isocratic mode utilizing 0.1M KH2PO4 : Methanol (60:40) at a flow rate of 1.0ml/min and eluate was monitored at 280nm, with a retention time of 4.421 and 3.421minutes respectively using RP-HPLC method for Simultaneous estimation of bulk and pharmaceutical formulations. The method was validated and there response was found to be linear in the drug concentration range of 50µg/ml to150 µg/ml for Teneligliptin and 50µg/ml to150 µg/ml for MetforminHcl .The values of the correlation coefficient were found to1 for Teneligliptin and 0.999 for MetforminHcl   respectively. The LOD and LOQ for Teneligliptin were found to be 0.2725 and 0.9085 respectively. The LOD and LOQ for MetforminHcl were found to be 0.801 and 2.671 respectively. The method was extensively validated according to ICH guidelines [2] for Linearity, Accuracy, Precision, Specificity and Robustness

Keywords: Teneligliptin and MetforminHcl High performance liquid chromatography [3],Validation