Original Articles: 2012 Vol: 4 Issue: 4
RP-HPLC method development and validation of Dronedarone HCl in its Pure form and tablet dosage form
A simple, rapid, sensitive, reverse phase isocratic RP-HPLC method was developed for determination of Dronedarone in pure form and tablet dosage form. The method was carried out using Hypersil ODS 3V column (250 mm × 4.5 mm i.d., 5 μm particle size) with mobile phase comprised of Buffer: acetonitrile(42:58%v/v). Buffer use is Potassium dihydrogen phosphate buffer with pH 3.0 . The flow rate was set at 1.1 ml/min and effluent was detected at 220nm. The retention time of Dronedarone was found to be 4. minute. The method was validated for specificity, accuracy, precision, linearity, and limit of detection, limit of quantification, robustness and solubility stability. LOD and LOQ were found to be 0.87 μg/ml and 2.66 μg/ml respectively. The calibration curve was linear in the concentration range of 10-150 μg/ml with coefficient of correlation 0.9999. The percentage recovery for the Dronedarone was found to be 99.3 and the % RSD was found to be less than 2 %. The proposed method was successfully applied for quantitative determination of Dronedarone in tablet dosage form.