Key result
Propafenone hydrochloride was highly susceptible to oxidative and thermal degradation, whereas an alkaline medium had an insignificant impact on its stability.
Propafenone hydrochloride is highly susceptible to oxidative and thermal degradation, which is important for evaluating the quality and safety of its drug products.
Propafenone products may require enhanced oxidative/thermal stability controls; Level 5 animal data leaves open clinical translation.
Propafenone hydrochloride is used in the treatment of supraventricular and ventricular arrhythmias and it has sodium channel blocking and β‐blocking activity. To evaluate the quality, safety and efficacy of propafenone drug products, a stability‐indicating method must be used, aiming at qualitative and/or quantitative assessment of the impurities and degradation products contained therein. The main purpose of this study was to develop and apply hyphenated high‐performance liquid chromatography with diode array detection and liquid chromatography with mass spectrometry methods to access susceptibility of the propafenone hydrochloride to stress conditions. The degradation process and products were systematically evaluated through in silico and predictive mass balance approaches. The main acidic and oxidative degradation product was characterized by using liquid chromatography with mass spectrometry. Propafenone hydrochloride was found to be highly susceptible to oxidative (peroxide) and thermal degradation. However, an alkaline medium has an insignificant impact on the stability of propafenone hydrochloride. A plausible path for the acidic degradation product is described and elucidated.
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Leite et al. (2018) studied this question. Propafenone hydrochloride was evaluated on Degradation process and products under stress conditions. Propafenone hydrochloride was highly susceptible to oxidative and thermal degradation, whereas an alkaline medium had an insignificant impact on its stability.
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