Current Issues of Pharmacy and Medical Sciences

Stability indicating HPLC method for the simultaneous determination of dapagliflozin and saxagliptin in bulk and tablet dosage form

Curr Issues Pharm Med Sci., Vol. 31, No. 1, 39-43

Thiyagarajan Deepan1,2, Magharla Dasaratha Dhanaraju2*

Research Scholar, Krishna University, Andhra Pradesh, India
2 Research Lab., GIET School of Pharmacy, Chaitanya Knowledge City, Rajahmundry, 533294 Andhra Pradesh, India

DOI: 10.1515/cipms-2018-0009

Abstract

A simple, fast, and highly selective RP-HPLC method was developed for the determination of Dapagliflozin (DAP) and Saxagliptin (SAX) in API and tablet dosage form. The separation was done using a Xterra RP18 (4.6×150 mm, 5 μm particle size) column with Acetonitrile: water (60:40). The isocratic elution mode at a flow rate of 1 mL/min, and the analytes were measured at 248 nm. The retention time for DAP and SAX were about 2.091 and 3.249 min, respectively. Calibration curves were found to be linear in the ranges of 100-500 μg/ml for DAP and 50-250 μg/ml for SAX, with correlation coefficients of 0.9998. The detection and quantification values for DAP was 3.0 and 9.98 μg/ml and SAX was 3.02 and 10 μg/ml respectively.

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Keywords

Dapagliflozin, Saxagliptin, HPLC, degradation studies, stability indicating.

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