LIQUID-CHROMATOGRAPHIC DETERMINATION OF AMIODARONE HYDROCHLORIDE AND RELATED-COMPOUNDS IN RAW-MATERIALS AND TABLETS

A liquid chromatographic method for the determination of amiodarone hydrochloride and 10 related compounds in drug raw material and for assay of drug in tablets was developed. The method specifies a 3 mu m Hypersil nitrile column (150 x 4.6 mm), a mobile phase of 1 + 1 acetonitrile-ammonium acetate buffer (0.1M adjusted to pH 6.0 with 0.1M acetic acid), a flow rate of 1 mL/min, and detection at 240 nm. The lower limit of quantitation of the related compounds is 0.02% or less. Drug contents in 2 raw material samples were 100.1 and 99.9% and ranged from 98.2 to 99.4% in 3 tablet formulations. Impurity levels in 2 samples of raw material from different manufacturers were ca 0.4%. The presence of 3 of the known related compounds in these samples was confirmed by liquid chromatography-mass spectrometry. The method applied to raw materials was evaluated by a second laboratory and found to be satisfactory.