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Stability‐indicating methods applied in the separation and characterization of the main degradation product of propafenone
Author(s) -
Oliveira de Almeida Leite Heitor,
Mohamad Kassab Nájla,
Prado Maria Segunda Aurora,
Singh Anil Kumar
Publication year - 2018
Publication title -
separation science plus
Language(s) - English
Resource type - Journals
ISSN - 2573-1815
DOI - 10.1002/sscp.201800073
Subject(s) - propafenone , chemistry , chromatography , degradation (telecommunications) , mass spectrometry , high performance liquid chromatography , medicine , telecommunications , computer science , cardiology , atrial fibrillation
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.