气相色谱法测定富马酸比索洛尔中有机残留量  

Residual Solvents determination in Bisoprolol Gemifrumarate by gas chromatography

作　　者：王少坚 符成龙[2] 

机构地区：[1]海南赛立克药业有限公司,海南海口571124 [2]海南碧凯药业有限公司,海南海口570216

出　　处：《海南医学院学报》2007年第5期418-419,共2页Journal of Hainan Medical University

摘　　要：目的:建立富马酸比索洛尔原料药中乙醇及乙酸乙酯残留量的测定方法:方法:采用气相色谱法测定,色谱柱为AT.PEG-20 M毛细管柱(30 m×0.53 mm×1.0μm),以N2为载气,FID检测器,进样口温度:200℃,检测器温度:250℃,柱温为程序升温:初始温度40℃保持3 min,以每分钟8℃的速度升至180℃,N2流量为7 mL/min,分流比为20∶1。结果:待测物均得到较好的分离,且线性关系良好。结论:本方法简便,可用于富马酸比索洛尔原料药中有机溶剂残留量的测定。Objective： To establish a method for the limit test of ethyl alcohol and ethyl acetate in Bisoprolol Gemifrumarate.Methods： Gas chromatography（GC） determination was employed and chromatographic column was capillary column AT·PEG-20M（30m×0.53mm×1.0μm）,with FID detector and nitrogen as carrier gas,Injector temperature was 200 ℃ and the detector temperature was 250℃,column temperature was programmed and initial temperature was 40℃,maintained for 3 min,raised to 180℃ with a rate of 8℃·min-1.The flow rate of nitrogen was 7ml·min-1.The split ratio was 20∶1.Results： The solvents can be completely separated and good linear relationship within a certain range.Conclusion： The method is easy to apply in detection of residual solvents in Bisoprolol Gemifrumarate.

关 键 词：富马酸比索洛尔 乙醇 乙酸乙酯 残留溶剂 色谱法 气相 

分 类 号：R972[医药卫生—药品]