高效液相色谱荧光法测定血液透析器中双酚A溶出量  

Determination of bisphenol A dissolution in hemodialyzer by high performance liquid chromatography with fluorescence spectrometry

作　　者：郭利娟 孙兴霞 刘爱娟 亓晓庆 王晨晓 沈永 Guo Lijuan;Sun Xingxia;Liu Aijuan;Qi Xiaoqing;Wang Chenxiao;Shen Yong(Shandong Institute of Medical Device 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》2021年第7期34-37,46,共5页Chemical Analysis And Meterage

基　　金：山东省重点研发计划(2019GSF108007)。

摘　　要：建立高效液相色谱荧光法测定血液透析器中双酚A的溶出量。采用甲醇作为替代溶剂,模拟产品临床使用,循环5 h,以评估血液透析器临床接触量。双酚A的最佳激发波长和发射波长分别为232、314 nm。双酚A质量浓度在51.2~1024 ng/mL范围内与色谱峰面积线性关系良好,线性相关系数为0.9999,方法检出限为10.8 ng/mL。加标回收率为90.23%~104.21%,测定结果的相对标准偏差为0.8318%~3.661%(n=6)。该方法专属性强,可用于血液透析器中双酚A溶出量的测定。A method for determining the dissolution of bisphenol A in hemodialyzer by high performance liquid chromatography with fluorescence spectrometry was established.Methanol was used as an alternative solvent to simulate the clinical use of the product and circulate for 5 h to evaluate the clinical exposure of the hemodialyzer.The optimal excitation wavelength and emission wavelength of bisphenol A were 232,314 nm,respectively.The mass concentration of bisphenol A had good linear relationship with the chromatographic peak area in the range of 51.2-1024 ng/mL,the linear correlation coefficient was 0.9999,the detection limit of method was 10.8 ng/mL.The recoveries were 90.23%-104.21%,with the relative standard deviations of 0.8318%-3.661%(n=6).The method has high specificity,and can be used for the determination of bisphenol A dissolution in hemodialyzer.

关 键 词：血液透析器 双酚A 高效液相色谱荧光法 甲醇 

分 类 号：O657.7[理学—分析化学]