顶空气相色谱法测定药包材产品中环氧乙烷残留量

Determination of Ethylene Oxide Residue in Pharmaceutical Packaging Materials by Headspace gas Chromatography

建立了药包材产品中环氧乙烷残留量的顶空气相色谱分析方法。采用顶空气相色谱法,以DB-624(30 m×0.53 mm×3μm)色谱柱为分离柱,检测器为氢火焰离子化检测器(FID)。结果表明环氧乙烷能与其他色谱峰很好的分离,分离度大于2.0,环氧乙烷在0.3982~12.7424μg/mL的浓度范围内线性关系良好(R^(2)=1.0),方法的检出限(LOD)为0.025μg/mL,定量限(LOQ)为0.079μg/mL,加标回收率为93.6%~101.8%(n=9),相对标准偏差小于2%。该方法简单、快速、准确,可用于药包材产品中环氧乙烷残留量的检测。

A headspace gas chromatographic method for the determination of ethylene oxide residue in pharmaceutical packaging materials was developed.Headspace gas chromatography,DB-624(30 m×0.53 mm×3μm)capillary column and flame ionization detector(FID)were used.Ethylene oxide can be separated well from other chromatographic peaks(Separations were greater than 2.0).Ethylene showed good linear relationships with good correlation coefficients(R^(2)=1.0)in the prescribed concentration range(0.3982~12.7424μg/mL).The limits of detection(LOD)of the method was 0.025μg/mL,and the limits of quantification(LOQ)was 0.079μg/mL.The standard recovery was between 93.6%and 101.8%(n=9),and relative standard deviation of reproducibility was less than 2%.This method is simple,rapid and accurate.It can be used for the determination of ethylene oxide residue in pharmaceutical packaging materials.