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建立了气相色谱-质谱法监测多层共挤输液用袋中残留苯乙烯单体在注射液中的迁移量。使用Agilent DB-624毛细管柱,以苯乙烯D8作为内标,采用程序升温,顶空进样,由电子轰击源(EI)选择离子监测(SIM)模式进行检测。苯乙烯在50~500 ng/ml范围内线性关系良好,平均加样回收率(以水为基质)为99.1%,RSD为3.02%。本法定量限为0.03 ng/ml,方法灵敏。通过测定6批样品,结果提示苯乙烯单体在注射液中迁移的风险系数较小。
A gas chromatography-mass spectrometry (GC-MS) was developed to monitor the migration of residual styrene monomer in the injection solution. Using an Agilent DB-624 capillary column with styrene D8 as an internal standard, programmed temperature and headspace sampling were performed by EI mode selective ion monitoring (SIM) mode. Styrene showed a good linearity in the range of 50-500 ng / ml with an average recovery of 99.1% (based on water) and a RSD of 3.02%. The limit of quantitation of this method is 0.03 ng / ml with sensitive method. Through the determination of six batches of samples, the results suggest that styrene monomer migration in the injection of the risk coefficient smaller.