依西美坦原料药中残留溶剂检测方法的研究  

GC detection of residual solvents in exemestane

作　　者：吴健敏[1] 魏宁漪[1] 田雁玉[2] 

机构地区：[1]中国药品生物制品检定所,北京100050 [2]河南省南阳市药品检验所,南阳473061

出　　处：《药物分析杂志》2006年第2期244-246,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:检查依西美坦原料药中的有机溶剂残留量。方法:采用气相色谱法,色谱柱为 INNOWAX 弹性石英毛细管柱(聚乙二醇为同定液,30m×0.53mm×1.0μm),进样口温度200℃;氢火焰离子化检测器(FID)温度:230℃;柱温:程序升温,初始温度30℃,保持20min,以20℃·min^(-1)升温至200℃,保持7min;载气:氮气,流速:1.5mL·min^(-1);以 N-甲基吡咯烷酮为溶剂,正丁醇为内标物。结果:被测物均能得到很好的分离,峰面积与浓度呈良好的线性关系,精密度良好。结论:该法可用于依西美坦原料药中有机溶剂残留量检测。Objective ： To establish a method for detection of the residual solvents in exemestane substances. Method： The residual solvents in exemestane substances were determined by GC with INNOWAX capillary column （30 m × 0. 53 mm × 1.0 μm） with FID detector and nitrogen as the carries gas. The injector temperature was 200 ℃ , the detector temperature was 230 ℃, the column temperature rose by program, the initial temperature was 30 ℃ and maintained for 20 min, then raised to 200 ℃ with a rate of 20 ℃· min^-1 and maintained for 7 min. The flow rate of N2 was 1.5 mL · min^ -l Results： The solvents can be completely separated, and the calibration curves of each solvent had good linear relationship within a certain range. Conclusion： The method is accurate and reliable. It can be applied in detection of residual solvents in exernestane substances.

关 键 词：依西美坦 残留溶剂 气相色谱 

分 类 号：R917[医药卫生—药物分析学]