Characterization of Forced Degradation Products of Rufinamide by LC/QTOF/MS/MS, NMR and IR studies

Abstract

Rufinamide is a triazole derivative used as an anticonvulsant was subjected to stress degradation under various stress conditions of hydrolysis, oxidation, photolysis and thermal stress as per ICH guideline Q1A (R2). The drug was highly susceptible to acidic and alkaline hydrolytic stress conditions while it remained stable under neutral hydrolytic, oxidative, thermal and photolytic stress conditions. Overall, two degradation products (DP1 and DP2) were formed. DPs were separated by using simple isocratic mode of water and acetonitrile (50: 50, %v/v) on Xbridge C18 (250 mm × 4.6 mm; 5 μm) column. Characterization of DPs was done by using LC/MS/MS, NMR and FT-IR. Further, the mechanistic pathway for formation of two DPs and their fragmentation pathways were postulated. The developed HPLC isocratic method was validated as per ICH guidelines.