Development and validation of a simple and sensitive HPLC method for the determination of related substances in regorafenib tablets
Development and validation of a simple and sensitive HPLC method for the determination of related substances in regorafenib tablets
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一种简单、灵敏的高效液相色谱法测定瑞戈非尼片中有关物质的方法的建立和验证
DOI：
10.1007/s44211-022-00068-9
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发表时间：
2022
影响因子：
1.6
通讯作者：
Chang Shu
中科院分区：
文献类型：
--
作者：
Sijie Li;M. Jiang;Minyue Li;Penghui Hu;Mingbo Xu;Chang Shu
瑞戈非尼作为一种口服多激酶抑制剂，在抗肿瘤药物市场上显示出良好的发展前景。但是，尚无文献报告瑞戈非尼片中有关物质的测定方法。质量标准首次纳入欧洲药典。10.4直到2021年4月，但无法同时检测到7种已知杂质A、C、D、E、FP-A、FP-B和FP-C。本文建立了一种简便、灵敏的HPLC法测定瑞戈非尼片中的有关物质。在Polar-RP柱上进行测定，双波长检测设置为230 nm和260 nm。根据ICH指导原则对该方法进行了验证。此外，分析了杂质的可能来源，并进行了强制降解试验，为处方开发和储存条件提供了指导。本方法简便、灵敏、准确，可用于瑞戈非尼片中有关物质的测定。图形摘要高效液相色谱法测定瑞戈非尼片中有关物质
Regorafenib as an oral multi-kinase inhibitor has displayed a promising future in the anticancer drug market. However, there are no articles reporting the method for the determination of related substances in regorafenib tablets. A quality standard was first included in the Ph. Eur. 10.4 until April 2021 but could not detect seven known impurities A, C, D, E, FP-A, FP-B, and FP-C simultaneously. In this paper, a simple and sensitive HPLC method was established for the determination of related substances in regorafenib tablets. The determination was performed on a Polar-RP column with dual wavelength detection set at 230 nm and 260 nm. This method was validated according to the ICH guidelines. Furthermore, the possible sources of impurities were analyzed and forced degradation tests were performed, which provided guidance for formulation development and storage conditions. The established method is simple, sensitive and accurate for the determination of related substances in regorafenib tablets.Graphical abstractA specified and sensitive HPLC method for the determination of related substances in regorafenib tablets
高效液相色谱-紫外检测法定量测定人血浆中瑞戈非尼及其两种主要代谢物。
DOI：
10.1002/bmc.3730
发表时间：
2016
期刊：
Biomed Chromatogr.
影响因子：
--
作者：
Fujita K;Miura M;Shibata H.
通讯作者：
Shibata H.