Validated RP-HPLC method for simultaneous estimation of metformin hydrochloride and sitagliptin phosphate in bulk drug and pharmaceutical dosage form

A new simple isocratic RP-HPLC method was developed for the simultaneous estimation of Metformin Hydrochloride and Sitagliptin Phosphate in tablet formulation. The separation was achieved on SUPELCO C-18 analytical column (150cm ×4.6mm I.D., 3μm particle size) in isocratic elution mode with the mobile phase consisting of 10mM Potassium dihydrogen ortho phosphate (pH:3.00): Acetonitrile in the ratio of 65:35 v/v and the column was maintained at 25°C. The detection of eluent from the column was detected using UV detector at 256nm and the flow rate was maintained at 1.0 ml/min. The proposed method has permitted the quantification of Metformin Hydrochloride and Sitagliptin Phosphate in the linearity range of 100-300μg/ml and 10-30μg/ml. The method was validated in terms of system suitability, specificity, linearity and precision. The proposed method can be successfully applied in the quality control of bulk and pharmaceutical dosage forms.

Author(s): Deepali Gangrade and Amit Sharma

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