Abstract

Forced degradation study on dronedarone and application of validated stability-indicating HPLC-UV method in stability testing of dronedarone tablets

Author(s): Rajyalakshmi. Ch, Benjamin. T and Rambabu.C

A stability indicating reverse phase high performance liquid chromatography method has been developed for the estimation of Dronedarone in tablet dosage form. A symmetry C18 column having dimensions of 150×4.6mm and 3μm particle size, with mobile phase containing a mixture of acetonitrile and phosphate buffer in the ratio of 60:40 v/v was used. PH of mobile phase was adjusted to 6.8 with sodium hydroxide. The flow rate was 1ml/min and the column effluents were monitored at 290 nm. The retention time for Dronedarone was found to be 2.65min. The proposed method was validated in terms of linearity, accuracy, precision, LOD, LOQ and robustness. The LOD and LOQ were found to be 0.018μg/ml and 0.06μg/ml respectively. The method was found to be linear in the range of 10 – 50 μg/ml with regression coefficient (r = 0.9996). The % recovery for the Dronedarone was found to be 99.6 and the forced degradation studies were also carried out as per ICH guidelines. There was complete separation of degradation peak and Dronedarone peak, which demonstrate the specificity of assay method for estimation of Dronedarone in the presence of its degradation products; it can be employed as a stability indicating one. Due to simplicity, rapidity and accuracy of the proposed stability indicating HPLC method is useful for quality control analysis.

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