气相色谱法测定三种药品包材残留溶剂含量
CSTR:
作者:
作者单位:

作者简介:

通讯作者:

中图分类号:

基金项目:

国家自然科学基金项目(编号:53703407)


Determination of Residual Solvents in Three Kinds of Pharmaceutical Packaging Materials with Gas Chromatography
Author:
Affiliation:

Fund Project:

  • 摘要
  • |
  • 图/表
  • |
  • 访问统计
  • |
  • 参考文献
  • |
  • 相似文献
  • |
  • 引证文献
  • |
  • 资源附件
  • |
  • 文章评论
    摘要:

    目的:建立药品包材中残留溶剂的含量测定方法。方法:色谱柱为DM-WA(30 mm×0.25 mm×0.25 μm);程序升温,30 ℃保持10 min,以10 ℃/min上升至90 ℃,保持2 min,以90 ℃/min上升至160 ℃,保持5 min;进样口温度160 ℃;氢焰离子化检测器,温度220 ℃;以正己烷为内标定量。结果:丙酮、乙酸乙酯、丁酮、异丙醇、苯、甲苯的回归方程分别为Y=3.5638X+0.0120,Y=3.6619X+0.0099,Y=4.9390X+0.0104,Y=3.7315X+0.0042,Y=10.112X+0.0291,Y=10.258X+0.0370。蒙脱石散包材残留溶剂为甲苯,平均回收为97.2%,RSD=1.41%。结论:该方法准确、重现性好、灵敏度高,可用于药品包材残留溶剂的含量测定。

    Abstract:

    To establish a standard method for the determination of residual solvents in pharmaceutical packaging materials.Methods: Gas chromatography was performed with chromatographic column of DM – WAX (30 mm×0.25 mm×0.25 μm) and the temperatures of injection port and hydrogen flame ionization detector were set at 160 ℃ and 220 ℃ respectively.Temperature programme: the column temperature rose to 30 ℃ and hold for 10 mins; rose by 10 ℃ per minute from 30 ℃ to 90 ℃,and hold for 2 minutes,then by 90 ℃ per minute to 160 ℃ and hold for 5 minutes.n-hexane was the internal standard when determinating the content of residual solvents in different pharmaceutical packaging materials.Results: Acetone,ethyl acetate,butanone,isopropyl alcohol,benzene,toluene regression equations were Y=3.5638X+0.0120,Y=3.6619X+0.0099,Y=4.9390X+0.0104,Y=3.7315X+0.0042,Y=10.112X+0.0291,Y=10.258X+0.0370 respectively.The residual solvents in Montmorillonite powder packaging material is toluene,the average recovery is 97.2%,RSD=1.41%.Conclusion: The method is accurate,reproducible,high sensitivity,and can be used for the determination of residual solvents in pharmaceutical packaging materials.

    参考文献
    相似文献
    引证文献
引用本文

李丹丹,鲍先杰,林宏英,汪文琪,张志千,孙毅坤.气相色谱法测定三种药品包材残留溶剂含量[J].世界中医药,2015,10(04).

复制
相关视频

分享
文章指标
  • 点击次数:
  • 下载次数:
  • HTML阅读次数:
  • 引用次数:
历史
  • 收稿日期:2014-07-25
  • 最后修改日期:
  • 录用日期:
  • 在线发布日期: 2015-05-06
  • 出版日期:
文章二维码