Abstract

STABILITY INDICATING RP-HPLC METHOD (ISOCRATIC) DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE AND LOBEGLITAZONE SULPHATE IN SYNTHETIC MIXTURE

Dr. Avani N. Doshi* and Ms. Naiya Thakkar

ABSTRACT

For the quantitative measurement of Dapagliflozin propanediol monohydrate and Lobeglitazone Sulphate in synthetic mixture form in the presence of its degradants, a precise, accurate, robust, cost-effective, and isocratic stability indicating RP-HPLC method was developed and validated. The mobile phase comprises [potassium dihydrogen phosphate buffer (0.02 M, pH 4.0) and methanol in a volumetric ratio of 25:75% v/v at a flow rate of 0.9 ml/min, injection volume of 50 µl, and UV detection at 268 nm. Separation was accomplished using Gemini, C18 column. Lobeglitazone Sulphate and Dapagliflozin propanediol monohydrate were eluted with a run time of 12 minutes. This procedure was approved following ICH guideline Q2 (R1). The calibration plots for Dapagliflozin propanediol monohydrate and Lobeglitazone Sulphate have correlation coefficients of 0.9995 and 0.9996 over the concentration of 50 µg/ml and 50 µg/ml, respectively. For Dapagliflozin propanediol monohydrate and Lobeglitazone Sulphate, accuracy ranged from 98.7% - 101.2% and 100% to 102% respectively. The findings demonstrated the applicability of the devised approach for routine analysis of Teneligliptin hydrobromide, Lobeglitazone Sulphate monohydrate and Dapagliflozin propanediol monohydrate in a synthetic mixture form with its degradants. 

Keywords: Dapagliflozin propanediol monohydrate, Lobeglitazone Sulphate, RPHPLC, Stability indicating method, Validation.