| 引用本文: | 李佳妮,高芳,王建.GC和GC-MS测定阿那曲唑中的11种残留溶剂[J].中国现代应用药学,2015,32(5):578-582. |
| LI Jiani,GAO Fang,WANG Jian.Analysis of Eleven Residual Organic Solvent in Anastrozole by GC and GC-MS[J].Chin J Mod Appl Pharm(中国现代应用药学),2015,32(5):578-582. |
|
| 摘要: |
| 目的 建立GC测定阿那曲唑中的11种残留溶剂，用GC-MS对样品中检出的残留溶剂进行确证。方法 采用顶空进样，色谱柱为DB-624(6%氰丙基苯基-94%二甲基聚硅氧烷固定液)石英毛细管柱，柱温为40 ℃，维持7 min，以10 ℃·min-1速率升至180 ℃，维持4 min，二甲基甲酰胺为溶剂。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，精密度和回收率良好，通过GC-MS对样品中检出的残留溶剂进行了确证。结论 该法可用于阿那曲唑原料药中残留溶剂的检测。 |
| 关键词: 阿那曲唑 气相色谱法 气相色谱-质谱联用 残留溶剂 顶空进样 |
| DOI： |
| 分类号: |
| 基金项目:国家药典委员会国家药品标准提高研究项目 |
|
| Analysis of Eleven Residual Organic Solvent in Anastrozole by GC and GC-MS |
|
LI Jiani1, GAO Fang1, WANG Jian2
|
|
1.Zhejiang University of Technology, Hangzhou 310014, China;2.Zhejiang Institute for Drug Control, Hangzhou 310004, China
|
| Abstract: |
| OBJECTIVE To establish a method of GC for the determination of residual solvents in anastrozole, a method of GC/MS for the verification of residual solvents in anastrozole. METHODS DB-624 capillary column through head-space sampling mode was used. The column temperature was maintained at 40 ℃ for 7 min, then was raised to 180 ℃ at the rate of 10 ℃·min-1 and maintained at 180 ℃ for 4 min. The sample was dissolved in dimethylformamide. RESULTS The measured solvents were separated completely. The calibration curve of each solvent showed a good linear relationship with good precision and accuracy. The residual solvents in anastrozole were confirmed by GC-MS. CONCLUSION The established method is simple and reliable, which can be used for determination of residual solvents in anastrozole. |
| Key words: anastrozole GC GC-MS residual organic solvents head-space sampling |
