RESUMO
The aim of the research work is to study the degradation behaviour of Ibrutinib (IBN) which is performed under different stress conditions according to International Conference on Harmonization guidelines (ICH). The study included monitoring degradation of the Ibrutinib drug under acidic, base, oxidation, thermal and photolytic conditions followed by isolation and characterisation of degradation products (DP) by Liquid Chromatography Mass Spectrometry (LCMS), High resolution Mass Spectrometry (HR-MS/MS) and Nuclear Magnetic Resonance (NMR) studies. The IBN drug is stable under oxidation, thermal and photolytic conditions. The degradation of drug is observed under acidic and basic conditions. Two novel degradation products are formed which are not reported in the literature. The LCMS method has been developed for chromatographic separation of drug and its degradation products which were attained on C18 BEH UPLC column (50 mm X 2.1 mm, 1.7 µm). The combination of 0.05% Acetonitrile in water and 0.05% Formic acid in water are used as a mobile phase. The flow rate is 0.6 ml/min and UV wavelength monitored at 215 nm. Acetonitrile and water are used as diluents.
