顶空气相色谱法同时测定药品包装复合膜中9种残留溶剂

目的：建立一种用于测定药品包装复合膜中常见的9种残留溶剂含量的顶空气相色谱方法。方法：选用TR—WAX（30mm×0．53mm，1．0μm）毛细管色谱柱，载气（氮气）流速为2．0ml／min，采用程序升温：初始温度为50℃（保持0min），以20℃／min的速率升温至70℃（保持4min），再以40℃／min的速率升温至160℃（保持14min），FID检测器温度为230℃，进样口温度为230℃。结果：9种有机溶剂在20min内能很好的分离，9种残留溶剂线性关系良好，相关系数均大于0．998，加标回收率在90．8％～98．3％，相对标准偏差RSD（n=6）在2．63％～6．13％，检出限范围为0．004～0．008mg／m^2。结论：该法快速、准确、灵敏度高，适用于药品包装复合膜中溶剂残留量的同时测定。

Simultaneous determination of nine kinds of residual organic solvents in laminated films used for drug packages by head -space gas chromatography

Objective ： An analytical method was developed for the determination of 9 kinds of residual organic solvents in laminated films used for drug packages by head -space gas chromatography. Methods：The optimal chromatographic conditions are as follows ： a TR - WAX capillary column （ 30 mm × 0.53 mm, 1.0 μm ） , nitrogen as carrier gas with a flow rate of 2.0 ml/min, column temperature programmed from 50℃ （ hold 0 min ） to 70 ℃ at a rate of 20 ℃/min and kept at 70 ℃ for 4 min, and then from 70℃ to 160℃ at a rate of 40 ℃/min and kept at 160℃ for 14 min; flame ionization detector temperature 230℃ and injector temperature 230 ℃. Resuhs ： All the 9 kinds of organic residues were separated well within 20 min, the standard curves were linear （ r 〉 0.998） ,the recoveries were 90.8% - 98.3% with RSD （ n = 6） in the range of 2.63% - 6.13% , and the limits of detection （S/N = 3 ）were 0. 004 -0. 008 mg/m2. Conclusion：This method is rapid, convenient, sensitive and can be used for the determination of residual organic solvents in laminated films used for drug packages.