ABSTRACT:
This research investigation establishes a robust Reversed Phase high performance liquid chromatography method for the accurate quantification of Trelagliptin Succinate, a long acting dipeptidyl peptidase-4 inhibitor. To reduce method variability and make method stable we use quality by design framework. To evaluate effect like mobile phase composition and flow rate we used of central composite design. We successfully achieved chromatographic separation are C18 stationary phase and for mobile phase combination of methanol and 0.1% orthophosphoric acid (70. 30 v/v) and flow rate is 1 mL/min and detection at 278 nm, the symmetrical peak was observed with retention time of approximately 4.7 minutes. The technique was verified as per regulatory standard, result are excellent linearity (R2 = 0.9996) and recovery are 99.15% in tablet formulation. This technique provide highly sensitive and reliable method for routine industrial quality control.