Abstract

DEVELOPMENT AND VADLIDATION OF RP-HPLC METHOD FOR SIMULATANEOUS ESTIMATION OF SAXAGLIPTIN AND DAPAGLIFLOZIN

Charmy P. Desai*, Ankit B. Chaudhary and Bhoomi D. Patel

ABSTRACT

The present work describes a validated reverse phase high performance liquid chromatographic method for simultaneous estimation of saxagliptin and dapagliflozin in synthetic mixture. Chromatography was performed on a ODS inertsil C18 (250 mm x 4.6 mm i.d., 5 μm particle size) column with mobile phase containing 0.05M Potassium dihydrogen phosphate(pH4.5±0.1 using orthophosphoric acid) : Methanol (35: 65). The flow rate was 1.0 ml/min and the eluent was monitored at 227 nm. The selected chromatographic conditions were found to effectively separate Saxagliptin (RT- 2.68min) and dapagliflozin(RT- 5.8 min). (Figure-3) Linearity for Saxagliptin and Dapagliflozin were found in the range of 2.5-7.5 μg/ml and 5-15μg/ml respectively. The proposed method was found to be fast, accurate, precise, and reproducible and can be used for simultaneous estimation of these drugs.

Keywords: Saxagliptin, Dapagliflozin, Reversed-phase HPLC.