Fast Stability Indicating UPLC Method for Quantitative Analysis of Dronedarone in Pharmaceutical Dosage Form: Force Degradation Study

A simple, precise, rapid reproducible, selective, and stability indicating reverse phase UPLC method has been developed for the estimation of dronedarone in pharmaceutical dosage form. Estimation of dronedarone hydrochloride was achieved on Acquity BEH C18 (100 mm*2.1 mm) 1.7 μm column using buffer [20 mM KH2PO4 + 1 mL Triethylamine (pH=2.5 by orthophosphoric acid)] and methanol in ratio of 40 : 60 as mobile phase at 30°C. The flow rate was 0.4 mL/min and effluents were monitored at 290 nm. The method was validated with respect to linearity, accuracy, precision, LOD, LOQ, and robustness. The method was linear over the concentration range 0.38–90 μg/mL (r2=0.999), with a limit of detection and quantification of 0.1 and 0.38 μg/mL, respectively. Dronedarone was subjected to acid and alkali hydrolysis, chemical oxidation, dry heat degradation, and photo (sunlight) degradation. The degraded product peaks were well resolved from the drug peak with significant difference in their retention time value.