APPLICATION OF SPECTRAL METHODS TO STUDY THE STABILITY OF THE AMIODARONE HYDROCHLORIDE MICELLAR SOLUTIONS

The stability of micellar solutions of amiodarone hydrochloride in the presence of polysorbate-80 and benzyl alcohol at l_ex = 420 nm and l_em = 506 nm was studied by spectrofluorimetry. A scheme of the formation of mixed micelles consisting of nonionic surfactant polysorbate-80 molecules and cationic molecules of amiodarone with chloride ions as counter-ions is proposed. It is established that the presence of benzyl alcohol reduces the stability of mixed micelles and leads to the crystallization of amiodarone hydrochloride. It was shown that in the presence of acetate ions, substitution of counter-ions occurs and, as a result, the formation of crystals of amiodarone acetate takes place, which has the characteristic band of valence vibrations of the acetate carbonyl group ν_С=О at 1734 cm^-1 in the IR spectrum. The solubility values of amiodarone hydrochloride and amiodarone acetate in water at 20°C were determined to be 0.33 and 0.058 mg/mL. It is recommended to change the molar ratio of amiodarone hydrochloride and polysorbate-80 and also not to use benzyl alcohol and acetate-containing solutions to improve the stability of the injectable drug.

инъекционная лекарственная форма, амиодарона гидрохлорид, полисорбат-80, бензиловый спирт, мицеллообразование, смешанные мицеллы, амиодарона ацетат, флуоресцентная спектроскопия, ИК спектроскопия, injectable dosage form, amiodarone hydrochloride, polysorbate-80, benzyl alcohol, micelle formation, mixed micelles, amiodarone acetate, fluorescence spectroscopy, IR spectroscopy

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