VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF JANUMET XR (SITAGLIPTIN/METFORMIN HCL EXTENDED-RELEASE FIXED DOSE COMBINATION (FDC) CONTENT IN BULK AND PHARMACEUTICAL DOSAGE FORM

A simple, accurate, precise and rapid stability indicating reverse phase High performance chromatography method was used for estimation of Sitagliptin/metformin HCl ER tablets in bulk fixed-dose combination solid oral dosage form. The proposed analytical has been validated specificity, Linearity, Accuracy, Precision Robustness. achieved a Avantor, ACE C18 (Length 150 x Diameter 4.6mm Particle size 5µm) column with gradient flow. optimal chromatographic condition consisted mobile pH 3.5 at flow rate 1.2 mL/min, temperature 35°C, run time 17 minutes detector wavelength 210 nm (Sitagliptin& Propyl gallate Metformin HCl).