顶空毛细管柱气相色谱法测定口服药用塑料瓶中环氧乙烷残留量

Determination of Residual Epoxyethane in Oral Pharmaceutical Plastic Bottles by Headspace Capillary Gas Chromatography

关键词:  顶空毛细管柱气相色谱法  口服药用塑料瓶  环氧乙烷  残留量

Key words:  headspace capillary gas chromatography  oral pharmaceutical plastic bottles  epoxyethane  residual.

摘要:

目的建立环口服药用塑料瓶中氧乙烷残留量的顶空毛细管柱气相色谱测定法。方法采用HP-5 Polyethylene Glycol（30.0 m×320 μm×0.25 μm）色谱柱；氢火焰离子检测器；顶空平衡温度80 ℃，平衡时间20 min，柱温80 ℃，进样口温度200 ℃，检测器温度250 ℃；柱流速2.0 mL·min-1。结果在0.417 3～12.519 μg·mL-1内呈线性关系(r=0.999 6)；平均回收率为99.7%,RSD=0.3%。结论该方法准确、灵敏、简便，适用于对口服药用塑料瓶中环氧乙烷残留量的检测。

Abstract:

OBJECTIVE To develop a method for the determination of epoxyethane in oral pharmaceutical plastic bottles by headspace capillary gas chromatography.METHODS A HP-5 Polyethylene Glycol(30.0 m×320 μm×0.25 μm)capillary column and a FID detector was adopted.The headspace equivilent temperature was 60 ℃ for 20 min,the oven temperature was 80 ℃,inlet temperature was 200 ℃ and detector temperature was 250 ℃.The flow rate was 2.0 mL·min-1.RESULTS The method has a linear range between 0.417 3-12.519 μg·mL-1(r=0.999 6).The average recovery was 99.7%,RSD=0.3%.CONCLUSION This method is accurate,sensitive,simple,it can be used for determination of epoxyethane in oral pharmaceutical plastic bottles.