Dronedarone - CAS 141626-36-0
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Not Intended for Therapeutic Use. For research use only.
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Dronedarone is a Class III antiarrhythmic and a multi-channel blocker for atrial fibrillation. It blocks potassium, sodium, and calcium channels and also exhibits antiadrenergic properties.
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1.Validated HPLC and Ultra-HPLC Methods for Determination of Dronedarone and Amiodarone Application for Counterfeit Drug Analysis.
El-Bagary RI1, Elkady EF, Mowaka S, Attallah M. J AOAC Int. 2015 Nov-Dec;98(6):1496-502. doi: 10.5740/jaoacint.15-054.
Two simple, accurate, and precise chromatographic methods have been developed and validated for the determination of dronedarone (DRO) HCl and amiodarone (AMI) HCl either alone or in binary mixtures due to the possibility of using AMI as a counterfeit of DRO because of its lower price. First, an RP-HPLC method is described for the simultaneous determination of DRO and AMI. Chromatographic separation was achieved on a BDS Hypersil C18 column (150×4.6 mm, 5 μm). Isocratic elution based on potassium dihydrogen phosphate buffer with 0.1% triethylamine pH 6-methanol (10+90, v/v) at a flow rate of 2 mL/min with UV detection at 254 nm was performed. The second method is RP ultra-HPLC in which the chromatographic separation was achieved on an AcclaimTM RSLC 120 C18 column (100×2.1 mm, 2.2 μm) using isocratic elution with potassium dihydrogen phosphate buffer with 0.1% triethylamine pH 6-methanol (5+95, v/v) at a flow rate of 1 mL/min with UV detection at 254 nm.
2.Identification and characterization of stress degradation products of dronedarone hydrochloride employing LC-UV/PDA, LC-MS/TOF and MS(n) studies.
Chadha R1, Bali A2, Bansal G3. J Pharm Biomed Anal. 2016 Jan 25;118:139-48. doi: 10.1016/j.jpba.2015.10.028. Epub 2015 Oct 26.
Dronedarone HCl was subjected to forced decomposition conditions of hydrolysis (neutral, acidic and alkaline), oxidation, photolysis and thermal stress, as suggested in the ICH guideline Q1A(R2). The drug showed significant degradation under alkaline hydrolytic and alkaline photolytic conditions while it remained stable in neutral, acidic, thermal and oxidative conditions. In total, six degradation products (I-VI) were formed, which could be separated by chromatography on C18 (250 mm × 4.6 mm; 5 μ, Xterra) column using isocratic elution method. Detection wavelength was selected as 288 nm. Multi-stage (MS(n)) and MS/TOF accurate mass studies were carried out to establish the complete fragmentation pathway of the drug which in turn was utilized in characterization of the products. The degradation pathway of the drug leading to generation of products I-VI was postulated and this has not been reported so far.
3.The combined effects of ranolazine and dronedarone on human atrial and ventricular electrophysiology.
Hartmann N1, Mason FE1, Braun I1, Pabel S1, Voigt N2, Schotola H3, Fischer TH1, Dobrev D2, Danner BC4, Renner A5, Gummert J5, Belardinelli L6, Frey N7, Maier LS8, Hasenfuss G9, Sossalla S10. J Mol Cell Cardiol. 2016 Apr 4;94:95-106. doi: 10.1016/j.yjmcc.2016.03.012. [Epub ahead of print]
INTRODUCTION: Pharmacological rhythm control of atrial fibrillation (AF) in patients with structural heart disease is limited. Ranolazine in combination with low dose dronedarone remarkably reduced AF-burden in the phase II HARMONY trial. We thus aimed to investigate the possible mechanisms underlying these results.
4.Short-term effects of oral dronedarone administration on cardiac function, blood pressure and electrocardiogram in conscious telemetry dogs.
Saengklub N1, Youngblood B, Del Rio C, Sawangkoon S, Hamlin RL, Kijtawornrat A. J Vet Med Sci. 2016 Feb 26. [Epub ahead of print]
Dronedarone is a multichannel blocking antiarrhythmic drug that has been used for management of atrial fibrillation in humans, but the data in veterinary medicine are inadequate. The objective of this study was to determine the short-term effects of oral dronedarone on cardiac inotropy and lusitropy, blood pressure and electrocardiogram (ECG) in healthy dogs. A total of 6 beagle dogs were instrumented with telemetry units and sono-micrometry crystals to obtain left ventricular pressure-volume relationship, mean blood pressure (MBP) and ECG. Dogs were given orally dronedarone (20 mg/kg, twice per day) for 7 days. All parameters were obtained hourly at 4-8 hr after the first dose and at 12-, 96- (day 4) and 168-hr (day 7) after dosing. The results showed that dronedarone had no effect on inotropy and lusitropy, while it significantly lengthened PQ interval (P<0.001) and lowered MBP (P<0.05). Dronedarone also tended to reduce cardiac output (P=0.
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CAS 141626-36-0 Dronedarone

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