毛细管气相色谱法测定瑞舒伐他汀钙中有机溶剂残留量  

Determination of Residual Organic Solvents in Rosuvastatin Calcium by Capillary GC

作　　者：史敬芬 陈玉洁 史颖 张雅然 王程程 

机构地区：[1]石药集团中奇制药技术(石家庄)有限公司,石家庄050035

出　　处：《中国药师》2012年第5期621-623,共3页China Pharmacist

基　　金：科技部"十一五"重大新药创制项目(编号:2010ZX09401-402)

摘　　要：目的:建立毛细管气相色谱法测定瑞舒伐他汀钙中有机溶剂的残留量。方法:采用HP-FFAP毛细管色谱柱,载气为氮气,流速为6 ml·min^(-1);分流比为5:1;程序升温;氢火焰离子化检测器(FID),检测器温度250℃,进样口温度200℃;按外标法测定溶剂残留量。结果:乙醇、乙酸乙酯、四氢呋喃和甲苯分别在100.58～1 005.80(r=0.999 9)、102.00～1 020.00(r=0.999 9)、14.66～146.60(r=0.999 9)、19.12～191.20μg·ml^(-1)(r=0.999 9)范围内,线性关系良好;平均回收率分别为99.1%(RSD=2.0%),98.5%(RSD=1.6%),98.9%(RSD=1.8%),99.2%(RSD=2.1%)。结论:该方法专属性好、快速、简单、结果准确,可用于瑞舒伐他汀钙中有机溶剂残留量的测定。Objective：To develop a method for the determination of residual organic solvents in rosuvastatin calcium.Method： The capillary gas chromatography with programming temperature was established with FID detector and HP-FFAP capillary column.The temperature of the injector and the detector was 200℃and 250℃,respectively.The carrier gas was nitrogen with a flow of 6.0 ml ？ min^（-1）.The split ratio was 5：1.The residual organic solvents were determined by external standard method.Result：Ethanol,ethyl acetate,tetrahydrofuran and toluene showed good linearity within the range of 100.58 ~ 1 005.80（r =0.999 9）,102.00～1 020.00（r = 0.999 9）,14.66~146.60（r=0.999 9） and 19.12～191.2μg ？ ml^（-1）（r = 0.999 9） with the average recovery of 99.1%{RSD = 2.0%）,98.5%（RSD = 1.6%）,98.9%（RSD = 1.8%） and 99.2%（RSD =2.1%）,respectively.Conclusion：The method is rapid,simple,accurate and suitable for the analysis of residual organic solvents in rosuvastatin calcium.

关 键 词：瑞舒伐他汀钙 有机溶剂残留:毛细管气相色谱法 

分 类 号：R927.11[医药卫生—药学]