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
*corresponding author: gtantaru2@yahoo.com
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Abstract:

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%).

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