更昔洛韦残留溶剂分析方法验证

Analysis Method Validation of Residual Solvent of Ganciclovir

更昔洛韦在生产过程中大量使用甲醇、乙醇、乙酸乙酯、N,N-二甲基甲酰胺,四者均属ICH限制使用的有机溶剂,其中甲醇、N,N-二甲基甲酰胺为二类溶剂,乙醇、乙酸乙酯为三类溶剂,为保证药品质量,对这两类溶剂均需加以控制。药品残留溶剂测定大多采用毛细管分析法,此法灵敏度高,对色谱系统影响小。参照《中国药典》2010年版二部附录"残留溶剂测定法",建立了甲醇、乙醇、乙酸乙酯和N,N-二甲基甲酰胺残留量测定方法。经各项方法学研究,确认方法简单、灵敏,准确度高,重现性好,适用于产品质量控制。

In the production process of ganciclovir, there are four kinds of solvents： methanol, ethanol, ethyl acetate, N,N-dimethyl formamide, which were contained into ICH limits. Here, methanol and N,N-dimethyl formamide belong to grade II solvents, ethanol and ethyl acetate belong to grade III solvents. The two kinds of solvents should be controlled to ensure the products＇ quality. Capillary analysis method is usually used to test residual solvents because of its high sensitivity and small influence on the chromatographic system. The testing method of residues of methanol, ethanol, ethyl acetate, N,N-dimethyl formamide were established according to the Chinese pharmacopoeia 2010, volumⅡ＂Method for determination of residual solvents＂. The studies by various methods confirms that this method was simple, sensitive,accurate, reproducible, applicable for the quality control of products.