EVALUATION AND VALIDATION OF A UPLC METHOD FOR SIMULTANEOUS ESTIMATION OF METFORMIN AND SITAGLIPTIN IN ORAL DOSAGE FORM

Dr. Osman Ahmed*, Mohd. Kareem Ahmed* and Dr. Anas Rasheed

ABSTRACT

A specific, precise, accurate ultra pressure liquid chromatography (UPLC) method is developed for estimation of Metformin + Sitagliptin in bulk drug and market dosage form. The method employed, with Hypersil C18 (100 mm x 2.1 mm, 1.7 μm) in a gradient mode, with mobile phase of Octane sulphonic acid buffer : acetonitrile 35:65 %v/v. The flow rate was 1.0 ml/min and effluent was monitored at 260 nm. The method was validated in terms of linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ) etc. in accordance with ICH guidelines. Linear regression analysis data for the calibration plot showed that there was good linear relationship between response and concentration in the range of 20- 100 μg/ml respectively. The LOD and LOQ values for were found to be 2.098(μg/ml) and 6.3597(μg/ml) respectively. No chromatographic interference from excipients and degradants were found. The proposed method was successfully used for estimation of Metformin + Sitagliptin in market dosage form.

Keywords: Metformin, Sitagliptin, oral dosage form, UPLC method.