University Institute of Pharmaceutical Sciences, UGC Center of Advanced Study, Panjab University, Chandigarh, India.
Eur J Mass Spectrom (Chichester). 2023 Aug;29(4):248-261. doi: 10.1177/14690667231194814.
The anticancer drug ibrutinib was subjected to stress degradation studies under the ICH-prescribed hydrolytic, photolytic, oxidative and thermal stress conditions, and its degradation behavior was studied. A significant degradation was noted for the drug under acidic/alkaline hydrolytic, acid/alkaline photolytic, and oxidative conditions. The UPLC-UV/PDA studies revealed the generation of six degradation products (), and these were adequately resolved from the drug under the developed chromatographic conditions over a Kinetex® C18 (100 mm×4.6 mm; 2.6 μm) column employing isocratic elution method. Detection wavelength was selected as 289 nm. The UPLC-UV/PDA method conditions were extrapolated to UPLC-MS/TOF studies. All the six degradation products were found to be ionized in the total ion chromatogram, and the products could be identified and characterized from their mass spectral data. The possible degradation route of ibrutinib leading to generation of various products was also postulated.
抗癌药物依鲁替尼在 ICH 规定的水解、光解、氧化和热应力条件下进行了稳定性降解研究，并研究了其降解行为。在酸性/碱性水解、酸/碱性光解和氧化条件下，该药物有明显的降解。UPLC-UV/PDA 研究表明，生成了六种降解产物（），在开发的色谱条件下，这些产物在 Kinetex® C18（100 mm×4.6 mm；2.6 μm）柱上采用等度洗脱法从药物中得到充分分离。检测波长选为 289 nm。UPLC-UV/PDA 方法条件被推断到 UPLC-MS/TOF 研究中。所有六种降解产物在总离子色谱图中均被离子化，并且可以从它们的质谱数据中鉴定和表征这些产物。还提出了导致各种产物生成的依鲁替尼可能的降解途径。
