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Abstract
Amiodarone is a class III anti‐arrhythmic agent and one of the most powerful drugs used in the treatment of ventricular and supraventricular tachycardias. The drug is available in the market as tablet and injectable formulations. In this study, a repeatable reverse‐phase high performance liquid chromatographic method for quality control purposes only has been developed for the estimation of amiodarone hydrochloride in a dosage form. A C‐8 column was used in the study. The mobile phase consisted of methanol, water, and acetic acid in a 95:4:1 ratio and the pH adjusted to 4.0 with aqueous ammonia. Nortriptyline was chosen as the internal standard and a flow rate of 1.5 mL/min was used with the buffer and water in 98:2 concentrations. The retention time for amiodarone hydrochloride and nortriptyline was approximately 3.5 and 1.8 min, respectively. The analytical method was found to be linear and stability indicating with the relative standard deviation within and between days being 2.48% and 3.26%, respectively. The LOQ and LOD were found to be 3.12 mcg and 0.936 mcg, respectively.