Stress degradation studies of dronedarone in pharmaceutical dosage form by a validated stability-indicating LC method

Abstract

A simple, rapid, and precise method is developed for the quantitative estimation of dronedarone hydrochloride in presence of its degradants which are formed due to stress conditions. A chromatographic separation of the dronedarone and its degradants were achieved with Zorbax XDB C8, 150 x 4.6 mm, 3.5μm analytical column using aqueous solution of 0.05M ammonium acetate and acetonitrile (40:60 v/v). The instrumental settings are flow rate of 1.0 mL/min, column temperature at 30oC, and detector wavelength of 220 nm using a photodiode array detector. Observed theoretical plates and tailing factor for dronedarone were 6577 and 1.09 respectively. Dronedarone was exposed to thermal, photolytic, hydrolytic and oxidative stress conditions, and the stressed samples were analysed by the proposed method. Peak homogeneity data of dronedarone is obtained using photodiode array detector. The stressed sample chromatograms demonstrate the specificity of the method for the estimation dronedarone in presence of its degradants. The described method showed excellent linearity over a range of 10 - 300 μg/mL for dronedarone. The correlation coefficient is 0.999. The relative standard deviation of peak area for six measurements is always found to be less than 2%. The proposed method was found to be suitable and accurate for quantitative determination and stability study of dronedarone.