Romanian Society of Pharmaceutical Sciences
 

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VALIDATION OF A NEW HPLC METHOD USED FOR DETERMINATION OF AMIODARONE FROM THE COMPLEX WITH HYDROXYPROPYL-BETA-CYCLODEXTRIN AND FROM COMMERCIAL TABLETS

ANDREEA BOSÎNCEANU1, OANA-MARIA PĂDURARU2, CORNELIA VASILE2, IULIANA POPOVICI1, GLADIOLA ȚÂNTARU1*, LĂCRĂMIOARA OCHIUZ1

1"Grigore T. Popa" University of Medicine and Pharmacy Iasi, Faculty of Pharmacy, Department of Analytical Chemistry, 16th University Street, 700115, Iasi, Romania
2 ”Petru Poni” Institute of Macromolecular Chemistry, 41th A Grigore Ghica Alley, 700487, Iasi, Romania

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This paper presents the development and validation of a new, rapid, specific and simple HPLC method with UV detection used for the quantitative determination of amiodarone from its inclusion complex with hydroxypropyl-beta-cyclodextrin and from commercially available Cordarone® tablets. A HP 1090 Series II liquid chromatograph with multidiode detector and Thermo Fisher-Hypersil Betasil C18 (150 mm x 4.6 mm; 5 μm) chromatographic column was used. The UV detection wavelength was 254 nm and the retention time for amiodarone was 4.51 minutes. The method was linear in the concentration range 0.001-0.1 mg/mL, the detection limit was established to be 0.001986 mg/mL, the quantification limit was 0.006621 mg/mL, while the regression coefficient was r2 = 0.9996. Various validation parameters were studied: the precision of the system (RSD = 0.84%), the precision of the method (RSD = 1.06%) and the accuracy of the method (98.48% in the concentration range 97.33–100.03%).