| 顶空GC法测定培美曲塞二钠中有机溶剂残留量 |
| |
| 引用本文： | 张强,苏曼,蒋新华.顶空GC法测定培美曲塞二钠中有机溶剂残留量[J].齐鲁药事,2013(10):576-578. |
| |
| 作者姓名： | 张强 苏曼 蒋新华 |
| |
| 作者单位： | [1]山东省医疗器械产品质量检验中心,山东济南250101 [2]山东铂源药业有限公司,山东济南251400 [3]连云港华晨医药有限公司,江苏连云港222006 |
| |
| 摘 要： | 目的建立顶空气相色谱法测定培美曲塞二钠中有机溶剂乙醇、二氯甲烷、苯和N,N-二甲基甲酰胺(DMF)含量的方法。方法采用顶空气相色谱法,载气为氮气,FID检测器,色谱柱为DB-624毛细管柱,外标法测定了培美曲塞二钠中4种有机溶剂的残留量。结果该气相色谱条件下4种有机溶剂完全分离,该方法线性关系良好,精密度和准确度符合要求。结论该方法快捷、灵敏、准确,适用于培美曲塞二钠中残留溶剂的测定。
|
| 关 键 词： | 顶空进样 GC 培美曲塞二钠 有机溶剂残留量 |
Determination of residual organic solvents in pemetrexed disodium by Headspace GC |
| |
| ZHANG QiangI,SU Man,JIANG Xin-hua.Determination of residual organic solvents in pemetrexed disodium by Headspace GC[J].qilu pharmaceutical affairs,2013(10):576-578. |
| |
| Authors: | ZHANG QiangI SU Man JIANG Xin-hua |
| |
| Institution: | 3 ( 1. Shandong Quality Inspection Center of Medical Equipment, Jinan 250101, China ;2. Shandong Boyuan Pharmaceutical Co. , Ltd. , Jinan 251400, China ;3. Lianyungang Huachen Pharmaceutical Co. , Ltd. , Lianyungang 222006, China } |
| |
| Abstract: | Objective To establish a method for the determination of residual ethanol, dichlormethane, benzene, and N,N - dimethylformamide （ DMF ） in Pemetrexed Disodium by headspace gas chromatography. Methods The residual sol- vents were determined by headspace GC on DB - 624 column with FID detector, and nitrogen was selected as the carrier gas. The amounts of the residual solvents were calculated according to the external standard method. Results In this chro- matography conditions,the four residual solvents were well separated,and the method shown that it had a good linear rela- tionship and the precision and accuracy were accorded with the requirements. Conclusion The method was simple, rapid, sensitive,accurate. It can be used to determine residual organic solvents in Pemetrexed Disodium. |
| |
| Keywords: | Headspace sampling GC Pemetrexed Disodium Residual organic solvents |
| 本文献已被 维普 等数据库收录！ |
|
