Abstract
The objective of the current study was to develop a validated, specific and stability-indicating reverse phase HPLC method for the quantitative determination of Dronedarone and its related substances. The determination was done for active pharmaceutical ingredient and its pharmaceutical dosage forms in the presence of degradation products, and its process-related impurities. The drug was subjected to stress conditions of hydrolysis (acid and base), oxidation, photolysis and thermal degradation per International Conference on Harmonization (ICH) prescribed stress conditions to show the stability-indicating power of the method. Significant degradation was observed during acid, oxidative and photo stress studies. In the developed HPLC method, the resolution between Dronedarone and its process-related impurities was found to be greater than 2.0. Regression analysis shows an r value (correlation coefficient) of greater than 0.999 for Dronedarone and it’s all the five impurities. The chromatographic separation was achieved on a C8 stationary phase. The method employed a linear gradient elution and the detection wavelength was set at 288 nm. The stress samples were assayed against a qualified reference standard and the mass balance was found to be close to 99.6%. The developed HPLC method was validated with respect to linearity, accuracy, precision and robustness.
Highlights
Dronedarone is a drug mainly for the indication of cardiac arrhythmias, chemically as N-(2-Butyl-3-(p-(3(dibutylamino)propoxy)benzoyl)-5-benzofuranyl)methanesulfonamide and its structural formula is C31H44N2O5S
The developed HPLC method was validated with respect to linearity, accuracy, precision and robustness
Multaq is generic name for Dronedarone, is recommended 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]
Summary
Dronedarone is a drug mainly for the indication of cardiac arrhythmias, chemically as N-(2-Butyl-3-(p-(3(dibutylamino)propoxy)benzoyl)-5-benzofuranyl)methanesulfonamide and its structural formula is C31H44N2O5S. Dronedarone falls under the category of multiple ion channel blocker It mainly targets the repolarization currents, making them less active and prolonging the action potential duration (APD). Dronedarone has been proven to be a safe and efficacious AAD, evidenced by both animal and human studies. These studies showed that there was prolongation of the APD and absence of QT interval prolongation with long term administration of the drug. Dronedarone is significantly safer and effective in maintaining the sinus rhythm and reducing the ventricular proarrhythmias, justifying it for the long term treatment of atrial fibrillation compared to other antiarrhythmic drugs [2,3,4,5]
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
