高效液相色谱-串联质谱法测定药包材中的双酚A含量OA
Determination of Bisphenol A in Pharmaceutical Packing Materials by High Performance Liquid Chromatography-Tandem Mass Spectrometry
目的:建立高效液相色谱-串联质谱法测定药品包装用复合膜、袋中的双酚A含量.方法:采用C18色谱柱,以甲醇-水(80:20)为流动相,样品经乙醇超声提取并过滤后,进行高效液相色谱-串联质谱分析.结果:双酚A在0.004 992～0.099 840 μg·mL-1浓度范围呈良好线性关系(r=0.999 3),检出限和定量限分别为0.001 498 μg·mL-1和0.004 992 μg·mL-1,加标回收率为96.9％,RSD为2.0％(n=6).结论:该方法专属性强,灵敏度高,结果准确,重现性好,可以用于药包材中双酚A的测定.
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.
董宇;刘静;姜鑫;王震红
辽宁省检验检测认证中心,辽宁省药品检验检测院,辽宁沈阳 110036辽宁省检验检测认证中心,辽宁省药品检验检测院,辽宁沈阳 110036辽宁省检验检测认证中心,辽宁省药品检验检测院,辽宁沈阳 110036辽宁省检验检测认证中心,辽宁省药品检验检测院,辽宁沈阳 110036
医药卫生
高效液相色谱-串联质谱法药包材双酚A迁移试验
High performance liquid chromatography-tandem mass spectrometryPharmaceutical packaging materialsBisphenol AMigration test
《中国药物评价》 2026 (2)
112-116,5
2025年国家药品评价性抽验项目(69)
评论