高效液相色谱法测定一次性使用注射器中双酚A溶出量
孙兴霞,郭利娟,张丽莹,杨婧,沈永
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
Determination of the dissolution of bisphenol A in disposable syringes by high performance liquid chromatography
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 ofBiomaterials and Medical Devices, Shandong Key Laboratory of Biological Evaluation for Medical Devices, Jinan 250101, China
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0.2 μm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,3.5 μm)分离,以荧光检测器检测。双酚A质量浓度在52.5~1050.0 ng/mL范围内与色谱峰面积线性良好,线性相关系数为0.9999。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)。
Abstract: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 0.2 μm 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 RP column (150 mm×4.6 mm, 3.5 μm), 18 and detected by fluorescence detector. The mass concentration of bisphenol A had good linearity with the chromatographic peak area in the range of 52.5-1 050.0 ng/mL with the linear correlation of 0.999 9, 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
Keywords:disposable syringes; bisphenol A; dissolution; high performance liquid chromatography
本文引用格式:
孙兴霞,郭利娟,张丽莹,等.高效液相色谱法测定一次性使用注射器中双酚A溶出量[J].化学分析计量,2023,32(3):79.
SUN Xingxia,GUO Lijuan,ZHANG Liying,et al. Determination of the dissolution of bisphenol A in disposable syringes by highperformance liquid chromatography[J]. Chemical Analysis and Meterage,2023,32(3):79.
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