A VALIDATED RP-HPLC METHOD FOR ESTIMATION OF DAPAGLIFLOZIN IN BULK AND TABLET DOSAGE FORM
Kavana D. C.*, Naveen Kumar G. S. and Suresh D. N.
A simple, rapid, precise, sensitive and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative analysis of Dapagliflozin in pharmaceutical dosage form. Chromatographic separation of Dapagliflozin was achieved on Prominence LC-20A Quaternary Gradient HPLC system, by using Shimpack C-18 (5μm, 4.6 x 250mm) column and the mobile phase containing Methanol and water with 0.1% ortho phosphoric acid with pH of 4.5 in a 80:20v/v ratio. The flow rate was 1.0ml/min; detection was carried out by absorption at 224nm using a UV detector at ambient temperature. LOD and LOQ were found to be 1.279 μg/ml and 3.877 μg/ml respectively and retention time was found to be 3.935mins. The % Recovery was found to be 99.93%-100.29%. The number of theoretical plates and tailing factor for Dapagliflozin were not less than 2000 and not more than 2 respectively. % Relative standard deviation of peak areas of all measurements always less than 2.0. The proposed method was validated according to ICH guidelines. The method was found to be simple, economical, suitable, precise, accurate and robust method for quantitative analysis of Dapagliflozin.
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