中国药物评价2026，Vol.43Issue(2)：112-116,5.
高效液相色谱-串联质谱法测定药包材中的双酚A含量
Determination of Bisphenol A in Pharmaceutical Packing Materials by High Performance Liquid Chromatography-Tandem Mass Spectrometry
摘要
Abstract
Objective:To establish a high performance liquid chromatography-tandem mass spectrometry method for the determination of Bisphenol A in laminated films and pouches for pharmaceutical packing.Methods:A C18 column was used with methanol-water(80:20)as the mobile phase.After ultrasonic extraction with ethanol,the sample was filtered and analyzed by high performance liquid chromatography-tandem mass spectrometry.Results:Bisphenol A showed a good linear relationship within the concentration range of 0.004 992-0.099 840 μg·mL-1(r=0.999 3).The limit of detection and limit of quantification were 0.001 498 μg·mL-1 and 0.004 992 μg·mL-1,respectively.The spiked recovery was 96.9％with an RSD of 2.0％(n=6).Conclusion:The method is spe-cific and sensitive,has accurate results and good repeatability,and can be used for the determination of Bisphenol A in pharmaceutical packaging materials.关键词
高效液相色谱-串联质谱法/药包材/双酚A/迁移试验Key words
High performance liquid chromatography-tandem mass spectrometry/Pharmaceutical packaging materials/Bisphenol A/Migration test分类
医药卫生引用本文复制引用
董宇,刘静,姜鑫,王震红..高效液相色谱-串联质谱法测定药包材中的双酚A含量[J].中国药物评价,2026,43(2):112-116,5.基金项目
2025年国家药品评价性抽验项目(69) （69）
