气相色谱法测定双醋瑞因中有机溶剂残留量  

Determination of residual organic volatile solvents in diacerein by capillary gas chromatography

作　　者：陈雪帆[1] 胡楚楚[1] 李会林[1] 许胜龙 

机构地区：[1]浙江省食品药品检验所,杭州310004 [2]台州海辰医药化工有限公司,浙江台州317016

出　　处：《中国新药杂志》2009年第20期1999-2001,共3页Chinese Journal of New Drugs

摘　　要：目的:建立双醋瑞因中有机溶剂残留量的测定方法。方法:采用高效毛细管色谱柱HP-INNO-WAX(30m×0.32mm,0.5μm),以聚乙二醇为固定相,应用程序升温,检测器为FID,以四氢呋喃为內标物,直接进样法测定双醋瑞因中甲醇、甲苯、乙醇、丙酮、N,N-二甲基乙酰胺等溶剂残留量。结果:线性相关系数r>0.9950;平均回收率为95.5%～103.6%,RSD≤2.0%(n=8),最低检出浓度为0.67～4.19μg·mL-1。结论:经方法学验证,该方法灵敏、准确、可靠,适用于本品有机溶剂残留量的检测。Objective：To establish a GC method for determination of organic solvents remaining in diacerein.Methods：The method included uses of an HP-INNOWAX （30m×0.32 mm,0.5 μm） sillica capillary column,a detector of FID,and a direct injection.Results：Under these conditions,5 residual volatile organic solvents and the internal standard tetrahydrofuran were completely separated.The resolution and sensitivity were acceptable.The limits of detection were 0.674.19 μg·mL^-1.Conclusion：After repeated validation,the method is proved to be accurate,sensitive and reliable.It is suitable to be adopted in the analysis of the tested solvents.

关 键 词：双醋瑞因 气相色谱法 溶剂残留量 毛细管柱 

分 类 号：R927.2[医药卫生—药学]