高效液相色谱法测定一次性使用注射器中双酚A溶出量  

Determination of the dissolution of bisphenol A in disposable syringes by high performance liquid chromatography

作　　者：孙兴霞 郭利娟 张丽莹 杨婧 沈永 SUN Xingxia;GUO Lijuan;ZHANG Liying;YANG Jing;SHEN Yong(Shandong Institute of Medical Devices and Pharmaceutical Packaging Inspection,NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices,Shandong Key Laboratory of Biological Evaluation for Medical Devices,Jinan 250101,China)

机构地区：[1]山东省医疗器械和药品包装检验研究院,国家药品监督管理局生物材料器械安全性评价重点实验室,山东省医疗器械生物学评价重点实验室,济南250101

出　　处：《化学分析计量》2023年第3期79-83,共5页Chemical Analysis And Meterage

摘　　要：建立了一次性使用注射器中双酚A溶出量的高效液相色谱测定方法。取一次性使用注射器的外套部分,剪碎,以甲醇为替代溶剂,采用极限浸提的方式,评估一次性使用注射器中双酚A溶出量。浸提液经氮气浓缩至干,用甲醇复溶后,经0.2μm的PTFE滤膜过滤,以乙酸铵缓冲溶液(pH 4.0)-乙腈为流动相进行梯度洗脱,使用Waters BEH Shield RP18型色谱柱(150 mm×4.6 mm,3.5μm)分离,以荧光检测器检测。双酚A质量浓度在52.5~1 050.0 ng/mL范围内与色谱峰面积线性良好,线性相关系数为0.999 9。方法检出限为21.0 ng/mL,样品加标回收率为96.97%~101.12%,测定结果的相对标准偏差为0.99%~5.31%(n=6)。A high performance liquid chromatography method was established for the determination of the dissolution of bisphenol A in disposable syringes.The outer parts of the disposable syringes were cut into pieces,the methanol was used as a substitute solvent,and the exhaustive extraction was adopted to evaluate the dissolution of bisphenol A in disposable syringes.The leaching solution was concentrated to dryness by nitrogen,reconstituted in methanol,filtered through a 0.2μm PTFE membrane,eluted with ammonium acetate buffer solution(pH 4.0)-acetonitrile as the mobile phase for gradient elution,separated by using a Waters BEH Shield RP18 column(150 mm×4.6 mm,3.5μm),and detected by fluorescence detector.The mass concentration of bisphenol A had good linearity with the chromatographic peak area in the range of 52.5-1050.0 ng/mL with the linear correlation of 0.9999,and the detection limit of the method was 21.0 ng/mL.The recoveries of standard addition were 96.97%-101.12%,and the relative standard deviations of determination results were 0.99%-5.31%(n=6).

关 键 词：一次性使用注射器 双酚A 溶出量 高效液相色谱法 

分 类 号：O657.7[理学—分析化学]