Фармацевтика Аналитика Акта

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Validation of an HPLC-UV Method for the Determination of Amiodarone Impurities in Tablet Formulations

Fuad Al-Rimawi

A simple, precise, accurate, and stability-indicating liquid chromatographic method was validated for the determination of amiodarone hydrochloride impurities (amiodarone impurity D and impurity E) as well as for the determination of amiodarone hydrochloride in tablet formulations. Liquid chromatography with a UV detector at a wavelength of 240 nm using a C18 column was employed in this study. Isocratic elution was employed using a mixture of buffer solution pH 5.0, methanol, and acetonitrile (30:30:40, v/v/v). This method was validated for the determination of amiodarone hydrochloride in accordance with USP requirements for assay determination, which include accuracy, precision, selectivity, linearity and range. The current method demonstrates good linearity over the range of 0.005-0.015 mg mL-1 of amiodarone hydrochloride. The % recovery of the method is 99.7%. The precision of this method reflected by relative standard deviation of sample replicates is 0.80%. Validation of the same method for the determination of amiodarone impurity D and impurity E was also performed according to USP requirements for quantitative determination of impurities which include accuracy, precision, linearity and range, selectivity, and Limit of quantitation (LOQ). Low LOQ of amiodarone impurities using this method enables the detection and quantitation of these impurities at low concentration.