Table of Contents
ISRN Chromatography
Volume 2014, Article ID 962130, 7 pages
Research Article

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

1Department of Chemistry, Saurashtra University, Rajkot, Gujarat 360 005, India
2Arts, Commerce and Science College, Borsad, Anand, Gujarat 388540, India

Received 23 September 2013; Accepted 10 October 2013; Published 27 April 2014

Academic Editors: O. Briand and C. Deng

Copyright © 2014 Batuk Dabhi et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


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 () 1.7 μm column using buffer [20 mM KH2PO4 + 1 mL Triethylamine ( 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 (), 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.