Polymorphism analysis of fluconazole by Raman spectroscopy / 中国药学杂志

ABSTRACT

OBJECTIVE: To established a method for identification of different polymorphs of fluconazole by Raman spectra. METHODS: The analysis was performed by dispersive 780nm 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 products can be easily and quickly identified by Raman analysis.