气相色谱-质谱联用法对药用胶塞中8种多环芳烃浸出物的测定

Determination of Polycyclic Aromatic Hydrocarbons as Leachable in Medical Rubber Stopper by Gas Chromatography-Mass Spectrometry

目的建立一种气相色谱-质谱联用法测定药用胶塞在复方电解质注射液中8种多环芳烃浸出物的方法,并对3批复方电解质注射液进行检测。方法对建立的检测方法进行方法学验证,并将样品经固相萃取浓缩后,经InertCap 5MS/Sil色谱柱分离,以选择离子(SIM)模式检测。结果8种多环芳烃的线性相关系数(R^(2))≥0.991,方法检出限均<10.0 ng/ml,平均回收率为75.4%~95.8%。3批复方电解质注射液中均未检出8种多环芳烃。结论该研究建立的方法在检测多环芳烃中具有灵敏度高、专属性好、准确度高的优点。

Objective A gas chromatography-mass spectrometry method was established for the determination of 8 polycyclic aromatic hydrocarbons as leachables in medical rubber stopper and then 3 batches of multiple electrolytes injection were detected by this method.Methods The methodology validation were carried out.The leached samples were concentrated by solid phase extraction and separated by InertCap 5MS/Sil column and then they were inspected by gas chromatography-mass spectrometry with selected ion monitor(SIM)mode.Results The calibration curves of 8 polycyclic aromatic hydrocarbons were all linear with correlation coefficient(R^(2))no less than 0.991 and their method detection limits were less than 10.0 ng/ml.Their average recovery rates were 75.4%~95.8%.The leaching amount of 8 polycyclic aromatic hydrocarbons of 3 batches of multiple electrolytes injection were less than method detection limits.Conclusion The established method was sensitive,specific and accurate in detecting polycyclic aromatic hydrocarbons.