A Stability Indicating Method Development and Validation for Separation of Process Related Impurities and Characterization of Unknown Impurities of Tyrosine Kinase Inhibitor Ibrutinib Using QbD Approach by RP-HPLC, NMR Spectroscopy and ESI-MS.

A selective RP-HPLC method for separation and determination of potential-related impurities (process related and degradants) of Ibrutinib drug substance has been developed and validated. The separation was accomplished on a X-Bridge C18, (150 x 4.6 mm, 3.