Separation and Identification of Oxidative Degradation Products of Osimertinib Tablets by using HPLC, UPLC-QTOF-MS/MS and Evaluation of their in-silico Safety Assessment

Seema R. Saple, Arun D. Bhutnar, Vikas V. Vaidya, Suvarna S. Lohakare

Osimertinib Mesylate (OSM), Oxidative Degradation Products UPLC-QTOF-MS/MS, In-Silico Safety assessment.

The present study focused on identification of the Oxidative degradation products of Osimertinib (OSM) Tablets by using of high-resolution mass spectrometry. A Ultra Performance Liquid Chromatography (UPLC) coupled with high resolution time of flight (Q-TOF-MS) was used for identification of oxidative degradation products (DPs) of OSM. Three major degradation products (DPs) were formed and their separation was carried out on a non-polar stationary phase by high-performance liquid chromatography system (HPLC). Three oxidative degradants were identified with masses, DP-1 (532.2655), DP-2 (m/z 516.2802) and DP-3 (m/z 516.2657) in this study. Further, interpretation of high resolution spectral data of degradants was carried out and proposed the elemental composition, RDB (ring double bond), mass error in ppm and molecular structure. Additionally, the in-silico safety assessed through widely accepted and respected structure activity relation (QSAR) and statistical based software’s DEREK nexus^TM, and MultiCASE , Case Ultra^TM for all DPs and OSM

https://doi.org/10.31871/WJRR.11.3.13