Abstract
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.
Highlights
Dronedarone (DRO), N (2Butyl3 (p (3(dibutylamino) propoxy)benzoyl)-5-benzofuranyl) methane sulfonamide (Figure 1)
A literature review revealed that DRO has been determined and studied by several procedures; quantitative analysis of DRO in bulk drug and pharmaceutical dosage is formed by HPLC [2,3,4] and by HPTLC [5]
There is a report on the determination of the DRO in human plasma by liquid chromatography-tandem mass spectrometry [7]
Summary
Dronedarone (DRO), N (2Butyl (p (3(dibutylamino) propoxy)benzoyl)-5-benzofuranyl) methane sulfonamide (Figure 1). DRO is used as an alternative to amiodarone for the treatment of atrial fibrillation and atrial flutter in people whose hearts have either returned to normal rhythm or who undergo drug therapy or electric shock treatment to maintain normal rhythm [1]. A literature review revealed that DRO has been determined and studied by several procedures; quantitative analysis of DRO in bulk drug and pharmaceutical dosage is formed by HPLC [2,3,4] and by HPTLC [5]. The HPLC method for determination of DRO in plasma and myocardium has been reported [6]. There is a report on the determination of the DRO in human plasma by liquid chromatography-tandem mass spectrometry [7]. There is no method reported for quantification of dronedarone by UPLC
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
