Abstract
Resumo Amiodarone hydrochloride is one of the most important drugs used to treat arrhythmias. The USP monograph for amiodarone hydrochloride describes an HPLC method for the quantification of seven impurities, however, this method shows problems that result in unresolved peaks. Moreover, there is no monograph for tablets in this compendium. Thus, a stability indicating HPLC method was developed for the determination of amiodarone, its known impurities and degradation products in tablets. A detailed forced degradation study was performed submitting amiodarone API, tablets and placebo to different stress conditions: acid and alkaline hydrolysis, oxidation, metal ions, heat, humidity, and light. Amiodarone hydrochloride API was susceptible to degradation in all stress conditions. The tablets also showed degradation in all environments, except in acidic condition. The analytes separation and quantification were achieved on an Agilent Zorbax Eclipse XDB-C18 column (100 x 3.0 mm, 3.5 µm). The mobile phase was composed of 50 mM acetate buffer pH 5.5 (A) and a mixture of methanol-acetonitrile (3:4, v/v) (B) in gradient elution. The method was validated in the range of 350-650 µg/mL for assay and 10-24 µg/mL for impurities determination. Therefore, this method can be used both for stability studies and routine quality control analyses.
Highlights
Cardiovascular diseases are the number one cause of death in the world
The monographs for amiodarone hydrochloride raw material presented in those pharmacopeias describe an isocratic reversed-phase HPLC method for the quantification of seven impurities (A-G) (Figure 1)
Amiodarone active pharmaceutical ingredient (API) and tablets were exposed to 1.0 M NaOH for 15 hours at 60 °C in an oven
Summary
Cardiovascular diseases are the number one cause of death in the world. It is estimated that 17.7 million people died in 2015 from cardiac diseases, representing 31% of all global deaths (WHO, 2018). Arrhythmia can be defined as an abnormal heart rhythm. This means that the electrical impulses of the heart can happen faster, slower or erratically. Oral amiodarone is indicated to treat patients with recurrent ventricular tachycardia, fibrillation resistant to other drugs and to Amiodarone hydrochloride is used worldwide and its monograph is described in a large number of pharmacopeias, including the United States Pharmacopoeia (USP, 2017) and the British Pharmacopoeia (BP, 2018). The same analytical conditions are presented for amiodarone tablets monographs in BP and USP Pharmacopeial Forum. These compendia report other methods for the quantitative amiodarone assay (BP, 2018; USP, 2018)
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