毛细管气相色谱法测定异氟烷中的有机溶剂残留量  

Determination of Residual Organic Solvents in Isoflurane by Capillary Gas Chromatography

作　　者：宋更申[1] 张毅[1] 姜建国[1] 

机构地区：[1]河北省药品检验所,石家庄市050011

出　　处：《中国药房》2010年第17期1595-1596,共2页China Pharmacy

摘　　要：目的:建立以毛细管气相色谱法测定异氟烷中丙酮、N,N-二甲基甲酰胺、N-甲基吡咯烷酮等3种有机溶剂残留量的方法。方法:色谱柱为DB-624石英毛细管柱,柱温采用程序升温,检测器为氢火焰离子化检测器,检测器温度为250℃,进样口温度为150℃,以环己烷为溶解介质。结果:丙酮、N,N-二甲基甲酰胺、N-甲基吡咯烷酮的检测浓度的线性范围分别为0.1～5.00(r=0.9999)、0.0176～0.88(r=0.9999)、0.0106～0.53(r=1.0000)mg·mL-1;平均回收率为97.5%～98.7%(RSD=0.4%～0.6%);最低检出限为1.46～4.49ng;3批样品中3种有机溶剂残留量均符合《中国药典》要求。结论:该方法操作简便、精密度好,结果准确可靠,可用于异氟烷中有机溶剂残留量的测定。OBJECTIVE：To establish a capillary GC method for the determination of residual organic solvents including acetone, N,N-dimethylformamide and N-methyl pyrrolidone in isoflurane.METHODS：The residual organic solvents were separated on DB-624 capillary column using temperature programming. FID was used as detector with a temperature of 250 ℃,the inlet temperature was 150 ℃,and cyclohexane as the solvent. RESULTS：The linear ranges of acetone, N,N-dimethylformamide and N-methyl pyrrolidone were 0.1～5.00 （r=0.999 9）,0.017 6～0.88 （r=0.999 9）,0.010 6～0.53 （r=1.000 0） mg·mL-1 respectively. The average recoveries ranged from 97.5% to 98.7% with RSD ranged at 0.4%～0.6%.The detection limits were 1.46～4.49 ng.The residual levels for the three organic solvents in 3 batches of samples were all up to the standard stipulated in China Pharmacopeia. CONCLUSION：The method is simple,accurate,sensitive and reproducible,it can be used for the determination of the residual organic solvents in isoflurane.

关 键 词：异氟烷 有机溶剂 残留量 毛细管气相色谱法 

分 类 号：R927.1[医药卫生—药学] R971.2