Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE AND SITAGLIPTIN FROM SYNTHETIC MIXTURE

Thakkar Jay*, Neha Tiwari and Pragnesh Patani

ABSTRACT

A simple, accurate and precise HPLC method was developed and validated for Estimation of DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (DPM) and SITAGLIPTIN (SIT) from synthetic mixture. The separation was achieved under optimized chromatographic condition on Hypersil ODS C18 (250*4.6 mm, 5 μm) column with mobile phase consisting of acetonitrile: Buffer (Potassium dihydrogen phosphate 0.02M and pH was adjusted by ortho phosphoric acid) (pH 4) (70:30v/v) with gradient elution at a flow rate of 1 mL/min using column ambient temperature with UV detection at 254nm. The retention time for Dapagliflozin propanediol monohydrate and Sitagliptin were about 2.4 and 6.9 minutes respectively. The linearity was found to be in the concentration range of 5-25 μg/mL for Dapagliflozin propanediol monohydrate and 50-250 μg/mL for Sitagliptin . The % recoveries at 50%, 100% and 150% were found to be within the limit of 98-100%. The method was validated as per ICH guidelines; and the values were found to be within the limits. So, the proposed method was found to be simple, linear, accurate, precise, robust and specific.

Keywords: Dapagliflozin propanediol monohydrate (DPM), Sitagliptin (SIT), Validation, Synthetic mixture, HPLC.