Solid-state characterization and impurities determination of fluconazol generic products marketed in Morocco

查看全文 作　　者：Houda [1]Bourichi;Youness [2]Brik;Philipe [3]Hubert;Yahia [1]Cherrah;Abdelaziz [1]Bouklouze

机构地区：[1]Research Team of Pharmaceutical and Toxicological Analysis-Laboratory of Pharmacology and Toxicology, Faculty of Medicine and Pharmacy, Mohammed V University, Soussi, Rabat, Morocco;[2]Physicochemical Service, Drugs Quality Control Laboratory, Division of Drugs and Pharmacy, Ministry of Health, Rabat, Morocco;[3]Laboratory of Analytical Chemistry, Department of Pharmacy, CIRM (university of liège) B36-B40000, liège l, Belgium

出　　处：《Journal of Pharmaceutical Analysis》索引2012年第2卷第6期,共10页

摘　　要：In this paper, we report the results of quality control based in physicochemical characterization and impurities determination of three samples of fluconazole drug substances marketed in Morocco. These samples were supplied by different pharmaceuticals companies. The sample A, as the discovered product, was supplied by Pfizer, while samples B and C (generics), were manufactured by two different Indian industries. Solid-state characterization of the three samples was realized with different physicochemical methods as: X-ray powder diffraction, Fourier-transformation infrared spectroscopy, differential scanning calorimetry. High performance liquid chromatography was used to quantify the impurities in the different samples. The results from the physicochemical methods cited above, showed difference in polymorph structure of the three drug substances. Sample A consisted in pure polymorph Ⅲ, sample B consisted in pure polymorph Ⅱ, sample C consisted in a mixture of fluconazole Form Ⅲ, form Ⅱ and the monohydrate. This result was confirmed by differential scanning calorimetry. Also it was demonstrated that solvents used during the re-crystallization step were among the origins of these differences in the structure form. On the other hand, the result of the stability study under humidity and temperature showed that fluconazole polymorphic transformation could be owed to the no compliance with the conditions of storage. The HPLC analysis of these compounds showed the presence of specificimpurities for each polymorphic form, and a possible relationship could be exist between impurities and crystalline form of fluconazole. 关键词：杂质测定产品销售氟康唑摩洛哥表征固态傅里叶变换红外光谱法差示扫描量热法

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Solid-state characterization and impurities determination of fluconazol generic products marketed in Morocco

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