Degradation studies of Ibrutinib under stress conditions: Characterisation and structural elucidation of novel degradants.

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.