达沙替尼原料药的晶型分析

Crystal form identification of dasatinib in tablets

摘要: 建立片剂中达沙替尼原料药的晶型分析方法。使用X射线粉末衍射(XRPD)和固态核磁共振光谱(ssNMR)，分别对达沙替尼市售片剂施达赛^®；和依尼舒^®；中达沙替尼原料药的晶型进行分析。结果显示，施达赛^®；片剂中达沙替尼原料药为一水合物，而依尼舒^®；片剂中达沙替尼原料药为无水晶型。在施达赛^®；片剂中没有观察到无水晶型，而依尼舒^®；片剂中没有观察到一水合物。XRPD与ssNMR两种方法检测结果一致，均可用于固体片剂中达沙替尼原料药的晶型分析。
- 达沙替尼 /
- 多晶型 /
- X射线粉末衍射 /
- 固态核磁共振 /
- 晶型分析
Abstract: The aim of this study was to establish the methods to identify crystal form of dasatinib in tablets. X-ray powder diffraction(XRPD)and solid-state nuclear magnetic resonance(ssNMR)were used to analyze the crystal form of dasatinib in Sprycel^® tablets and Yinishu^® tablets. The results showed that monohydrate and anhydrate were identified in Sprycel^® and Yinishu^® tablets respectively, with no detectable anhydrate in Sprycel^® tablets and no detectable monohydrate in Yinishu^® tablets. The results of XRPD and ssNMR were consistent, and could be both applied in the crystal form identification of dasatinib in tablets.
- dasatinib /
- polymorph /
- X-ray powder diffraction /
- solid-state nuclear magnetic resonance /
- crystal form identification

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