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%).