拉曼光谱测定氟康唑晶型的应用研究

Polymorphism Analysis of Fluconazole by Raman Spectroscopy

目的建立了拉曼光谱法测定氟康唑两种晶型方法。方法选取氟康唑两种晶型原料药,通过X射线粉末衍射,红外光谱,热分析确认其晶型为A、B晶型,采用780 nm色散型拉曼光谱法得到A、B晶型拉曼光谱图,测定了3个不同厂家氟康唑固体口服制剂的晶型类别,并采用拉曼成像技术对含量分布进行初步研究。结果得到了氟康唑A、B晶型特征拉曼谱图,并确认了3个厂家制剂所含氟康唑晶型类别,其中T1样品除含有A晶型还含有淀粉类辅料,T3样品除含有B晶型还含有乳糖类辅料。结论本方法可应用于快速鉴别原料及固体口服制剂中氟康唑的不同晶型类别,方法便捷,具有较高的准确度及专属性。

OBJECTIVE To established a method for identification of different polymorpbs of fluconazole by Raman spectra. METHODS The analysis was performed by dispersive 780rim Raman system. Raman spectra of polymorphs A and B of fluconazole were obtained, and the result was verified by DSC, FTIR and Power X Ray Diffraction （PXRD）. Without any pre-treatment, Raman analysis was directly carried on three different fluconazole solid oral products and the polymorphs A or B of fluconazole in the raw material was indicated by Raman spectra. The distribution of polymorphism contents was studied by Raman imaging technology. RESULTS The characteristic Raman spectra of polymorphs A and B of fluconazole were obtained. And the polymorphisms of the three test products were determined. Sample T1 contained polymorph A and starch or dextrin as the main excipient. Sample T3 contained polymorph B and lactose as the main excipient. CONCLUSION The polymorphs A and B of fluconazole in the raw material and solid oral prod- ucts can be easily and quickly identified by Raman analysis.