A Simple and Sensitive RP-HPLC Method for Estimation of Dronedarone in Bulk and Tablet Dosage Forms

A simple, rapid, sensitive, accurate and precise HPLC method has been developed and validated for the estimation of Dronedarone in bulk and pharmaceutical dosage form. The method was carried out using XTerra Symmetry C18 (100 x 4.6 mm I.D., 5 μm particle size) column and mobile phase comprised of phosphate buffer pH 3.0 and acetonitrile in proportion of ratio 50:50 v/v and degassed in ultrasonic water bath. The flow rate was 0.8 mL/min and the detection wavelength was at 290 nm. The linearity was observed in the range of 10–60 μg/mL with a correlation coefficient of 0.999. The retention time of Dronedarone was 2.578 min. The method was validated as per the ICH guidelines for its linearity, precision, accuracy, specificity, limit of detection, limit of quantitation and by performing recovery studies. The percentage recovery of the drug Dronedarone was 99.0% to 101.5% from the tablet formulation. The proposed method is suitable for the routine quality control analysis for the estimation of Dronedarone in bulk and pharmaceutical dosage form.