Stability study of amiodarone hydrochloride in capsules for paediatric patients using a high-performance liquid chromatography method.

Abstract

Amiodarone hydrochloride, a class III antiarrhythmic agent, shows ß blocker-like and potassium channel blocker-like actions on the sinuatrial and atrioventricular nodes. It is given by mouth in the treatment of all forms of atrial, junctional and ventricular arrhythmias. Capsules for paediatric patients are not commercially available and must be prepared in the pharmacy department. The aim of the study was to evaluate the stability of amiodarone hydrochloride at different dosages, 10, 60 and 100 mg, in capsules for paediatric patients stored in three packages under dark conditions and at room temperatures over one year. At different intervals during the storage period, amiodarone hydrochloride concentration was tested using a high-performance liquid chromatography (HPLC) method. Amiodarone hydrochloride content remained greater than 95% of the initial concentration in all capsules at all dosages. The 10, 60 and 100 mg amiodarone paediatric capsules were stable for one year when stored in the three packages at ambient temperature and under dark conditions.