伊布替尼
化学
色谱法
质谱法
液相色谱-质谱法
高效液相色谱法
降级(电信)
布鲁顿酪氨酸激酶
酪氨酸激酶
生物化学
信号转导
白血病
医学
慢性淋巴细胞白血病
内科学
电信
计算机科学
作者
Rajender Reddy Yerla,Surendrababu Manubolusurya,Saravanakumar Meganathan,Veerababu Madalapu,Gopal Vaidyanathan
出处
期刊:Journal of Chromatographic Science
[Oxford University Press]
日期:2024-02-09
标识
DOI:10.1093/chromsci/bmae002
摘要
Abstract Ibrutinib is an orally administered compound that functions as an irreversible covalent inhibitor of the Bruton tyrosine kinase, an essential element in multiple cellular processes including B-cell differentiation, proliferation, migration, survival and apoptosis. The compound has been found to demonstrate efficacy against a range of B-cell malignancies. The drug product is available in oral tablet and capsule formulations. The drug degradation profiles of tablets dosage form were assessed in accordance with regulatory guidelines. The results indicate that the drug substance is susceptible to alkaline and oxidative stress. The oxidation degradation led to the identification of three significant unknown degradation impurities. The three compounds were isolated through the application of preparative liquid chromatography, and their structures were determined using analytical techniques such as liquid chromatography–mass spectrometry, high-resolution mass spectrometry and nuclear magnetic resonance spectroscopy. Utilizing structural elucidation data, predictions were made regarding the composition of impurities, revealing them to be novel degradation impurities that bear structural resemblance to ibrutinib. Additionally, potential pathways for the formation of the impurities were proposed.
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