Edoxaban is a novel anticoagulant drug acting as a direct, selective and reversible inhibitor of the coagulation factor Xa. Forced
degradation under acid condition was carried out in order to establish its stability towards acid hydrolysis. Edoxaban was subjected
to acid hydrolysis as per International Conference on Harmonisation ICH guidelines and found susceptible to acid. A linear gradient
and validated ultra-performance liquid chromatographic method was applied for the identification and characterization of acid
degradation products of Edoxaban in active pharmaceutical ingredient (API). Six major degradation products were detected, well
separated and determined by LC-MS, then three of them were isolated by semi-preparative HPLC and subjected to NMR spectroscopy
and FT-IR to characterize and elucidation of their most possible structures.
Keywords
Edoxaban, LC-MS, Stability Indicating, Acid Degradation Products, NMR, FT-IR