STABILITY-INDICATING HPLC-DAD METHOD FOR THE DETERMINATION OF IPRAGLIFLOZINE

ahmed mohamed abd elzaher

Abstract


A novel stability-indicative of RP-HPLC method was developed and validated for the quantitative estimation of ipragliflozin in bulk drugs and pharmaceutical dosage form in the presence of its forced degradation products. The drug was subjected to variable stress conditions including hydrolysis, oxidation, thermal and photolysis. The drug was found to be labile to acidic hydrolysis, basic hydrolysis, oxidation but stable in thermal, photolysis and neutral hydrolytic conditions. Successful chromatographic separation of ipragliflozin was achieved on HAMILTON column prp-x100C18 column at a flow rate of 1 mL/min using mobile phase composition of methanol : acetonitrile : Water in ratio of (50: 25 : 25, by volume). The eluents were monitored by the diode array detector and peak area values were measured at 230 nm. The validity of the method was assessed by evaluating accuracy, precision, specificity and robustness. The linear regression analysis data for the calibration curve shows a good relationship in the range of  10 – 100 µg/mL. The developed method was successfully applied for the estimation of  ipragliflozin in its commercial dosage form and could be used for the routine analysis of the studied drug in quality control laboratories.


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