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RP-UPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF SITAGLIPTIN AND DAPAGLIFLOZIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

Authors: Swati Nitin Prabhu, Surekha Kolhal, Nitin Prabhu & Rajesh Samant;

RP-UPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF SITAGLIPTIN AND DAPAGLIFLOZIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

Abstract

An RP-UPLC method for the simultaneous determination of Sitagliptin and Dapagliflozin in tablets was developed and validated as per ICH & FDA guidelines. The separation was achieved with a 50 mm x 2.1 mm, 1.7 µm C18 column by using a simple linear gradient. Mobile phase A was buffer (0.05% trifluoracetic acid), and mobile phase B was acetonitrile. A simple gradient program was delivered at a flow rate of 0.3 mL/min. The column temperature was kept at 25°C. The detector was set at the wavelength of 210 nm. Injection volume was 2 µL. The gradient separation was achieved within 3 minutes. The linearity of the proposed method was investigated in the range 0.25-0.75mg/mL (r2= 1.000) for Sitagliptin, and 0.025-0.075 mg/mL (r2= 1.000) for Dapagliflozin. The assay method is specific, as no blank and placebo interference was observed at the retention times of Sitagliptin and Dapagliflozin peaks. The developed method has an advantage that both drugs can be quantified alone or in combination using a single mobile phase, with time- and chemically efficient method.

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