超高效液相色谱-串联质谱法测定一次性使用输液器中双酚A的含量  

Determination of bisphenol A in disposable infusion set by UPLC-MS

作　　者：丁豪 DING Hao(Shanghai Food and Drug Packaging Materials Control Center,Shanghai 201203,China)

机构地区：[1]上海市食品药品包装材料测试所,上海201203

出　　处：《药物分析杂志》2023年第12期2121-2126,共6页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立检测一次性使用输液器中双酚A含量的超高效液相色谱-串联质谱法(UPLC-MS)。方法:采用ZORBAX Eclipse Plus C_(18)(50 mm×3.0 mm,1.8μm)色谱柱进行分离,选择甲醇、0.3%氨水为流动相进行梯度洗脱,多反应监测(MRM)模式检测,基质外标法定量。结果:双酚A的检测限和定量限分别为3.1、10.2 ng·mL^(-1),在10~200 ng·mL^(-1)范围内线性关系良好(r=0.9997),在pH 3.5缓冲溶液、pH 8.0缓冲溶液、15%乙醇溶液和0.9%氯化钠注射液中的加标回收率在90.8%~102.3%,应用于4批一次性使用输液器的检测,有1批被检出。结论:方法操作简单,结果准确稳定,灵敏度高,线性范围较宽,满足样品测定的要求,可用于一次性使用输液器中双酚A的检测分析。Objective:To establish an UPLC-MS method for the determination of bisphenol A in disposable infusion set.Methods:ZORBAX Eclipse Plus C_(18)column(50 mm×3.0 mm,1.8μm)was used for separation.Methanol and 0.3%ammonia were selected as mobile phases for gradient elution.Multiple reaction monitoring(MRM)mode was used for detection.Results:The limits of detection and quantitation of bisphenol A were 3.1 ng·mL^(-1)and 10.2 ng·mL^(-1),respectively.And the linear relationship was good in the range of 10-200 ng·mL^(-1)(r=0.9997).The recoveries of the added standard in pH 3.5 buffer solution,pH 8.0 buffer solution,15%ethanol solution and 0.9%sodium chloride injection were 90.8%-102.3%.The method was applied to the detection of 4 batches of disposable infusion sets,and bisphenol A was detected in 1 batch.Conclusion:The method is simple,accurate,stable,sensitive,and has a wide linear range.It can be used for the determination of bisphenol A in disposable infusion set.

关 键 词：超高效液相色谱-串联质谱法 双酚A 提取量 一次性使用输液器 

分 类 号：R917[医药卫生—药物分析学]