达沙替尼原料药的晶型分析

Crystal form identification of dasatinib in tablets

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(ss NMR),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。

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.