化学
降级(电信)
阿西替尼
质谱法
强制降级
核磁共振波谱
色谱法
有机化学
肝细胞癌
索拉非尼
甲酸铵
癌症研究
电信
生物
计算机科学
作者
Bhoopendra Singh Kushwah,Vijaya Madhyanapu Golla,Vivek Dhiman,Gananadhamu Samanthula
标识
DOI:10.1002/sscp.202200043
摘要
Abstract The prime focus of the present study includes forced degradation studies on axitinib and the characterization of novel degradation products formed. As per International Council for Harmonisation guidelines, axitinib was exposed to harsher conditions such as acidic, alkali, oxidative, photolytic, and thermal conditions. Axitinib was found unstable upon exposure to oxidative and photolytic conditions, generating a total of four degradation products. Out of four degradation products, three are novel and were not reported in the literature. The degradation products formed were well separated by high‐performance liquid chromatography and characterized by liquid chromatography‐high resolution mass spectrometric studies. Further, their structures were confirmed by nuclear magnetic resonance spectroscopic studies. The possible degradation products were characterized as sulfoxide, sulfone, isomeric and dimer impurities. A detailed mechanistic explanation for the formation of degradation products along with its in silico toxicity prediction was laid out.
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