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High performance liquid chromatographic method for routine monitoring of amiodarone and desethylamiodarone plasma levels.

The authors describe a normal phase liquid-chromatographic assay suitable for therapeutic monitoring of amiodarone and desethylamiodarone in human plasma. The compounds were extracted at pH 3.8 into methyl tert-butyl ether containing [2-ethyl-3-3.5-dibromo-4-dipropylaminoproxybenzoyl)benzothiophe ne] as internal standard. The separation was obtained by using a mobile phase of methanol-methyl tert butyl ether-sulfuric acid (60-40-0.015; v/v/v). The absorbance of the compounds was monitored at 254 nm with a sensitivity limit of 0.05 mg/l for amiodarone and 0.02 mg/l for desethylamiodarone. The mean overall recovery from plasma samples was greater than 90 p. cent for both compounds. This method was applied to therapeutic and pharmacokinetic studies.