艾拉莫德原料药中残留溶剂检测方法的研究  

GC Detection of Residual Solvents in Iguratimod

作　　者：李慧义[1] 魏京京[1] 朱维华[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《药物分析杂志》2004年第4期422-424,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:检查艾拉莫德原料药中的有机溶剂残留量。方法:采用气相色谱法测定,色谱柱为HP-5弹性石英毛细管柱(以5%苯基-95%甲基聚硅氧烷为固定液,1.5μm,30 m×0.53 mm);进样口温度:200℃;氢火焰离子化检测器(FID),检测器温度:300℃;柱温:程序升温,初始温度30℃,保持13 min,以5℃·min-1升温至35℃,保持7 min,再以10℃·min-1升温至230℃,保持5 min;载气:氮气;流速:1.5 mL·min-1;以N-甲基吡咯烷酮为溶剂,正丙醇为内标物。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:该法可用于艾拉莫德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 iguratimod substance. Method: The residual solvents in iguratimod substance were determined by GC with HP-5 capillary column (30 m×0. 53 mm,I. 5μm) with FID detector and nitrogen as the carries gas. The injector temperature was 200 ℃,the detector temperature was 300℃, the column temperature rose by program, the initial temperature was 30℃ , maintain for 13 min,raise to 35℃with a rate of 5℃·min-1,maintain for 7 min,then raise to 230℃with a rate of 10℃·min-1. The flow rate of N2 was 1. 5 mL·min-1. 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 iguratimod substance.

关 键 词：艾拉莫德 原料药 溶剂检测 气相色谱法 免疫调节作用 

分 类 号：R914[医药卫生—药物化学]