Volume :
3
Issue :
2
Abstract :
A simple, rapid, precise, accurate RP-HPLC method has been developed and validated for the simultaneous estimation of Sitagliptin and Metformin in combined dosage forms. Chromatographic separation was achieved with mobile phase consisting of Acetonitrile: Phosphate Buffer pH 3.0 in the ratio of 40:60 v/v with Supercil C18 (250 × 4.6 mm × 5 µm), column at a flow rate of 1 mL/min and detection wavelength was 236 nm. The retention times of Sitagliptin Phosphate and Metformin Hydrochloride was found to be 4.813 min and 2.390 min respectively. The method was validated in terms of Linearity, Range, Accuracy, Precision, Specificity, LOD, LOQ, Robustness and system suitability according to ICH guidelines. Commercial tablet formulation was successfully analyzed using the developed method and the proposed method is applicable to routine analysis for determination of Sitagliptin Phosphate and Metformin Hydrochloride in tablet dosage form.