Determination of Flecainide acetate and its degradation impurities by UPLC-MS

A sensitive UPLC-MS method was developed for the determination of Flecainide acetate in the presence of four its related impurities (Impurities: A, B, D and E). The forced degradation study of Flecainide acetate was carried out under acidic, alkali, neutral and oxidative conditions. The degradation was observed under acidic, neutral and oxidative conditions and four degradation products (impurities) were observed. Successful chromatographic separation of Flecainide acetate and its degradation products were achieved on a Waters Acquity BEH C18 column (100 mm x 2.1 mm x 1.7μ) using a mobile phase of solvent A (10 mM Ammonium formate) and solvent B (acetonitrile) in gradient elution. The gradient program employed to achieve the separation was (T_min/%Solvent B): 0/15, 1/15, 3/90, 5/90, 7/15, 9/15. The flow rate was maintained at 0.3 mL/min. The impurities were characterized and the fragmentation pathways for the impurities were proposed.