高效液相色谱法测定血液透析器中聚乙烯吡咯烷酮、N,N-二甲基乙酰胺和N-甲基吡咯烷酮溶出量  

Determination of the dissolution amount of polyvinylpyrrolidone,N,N-dimethylacetamide and N-methylpyrrolidone from hemodialyzer by high performance liquid chromatography

作　　者：陈华燕 黄麒谕 徐苏华[1] CHEN Huayan;HUANG Qiyu;XU Suhua(Guangdong Medical Devices Quality Surveillance and Test Institute,NMPA Key Laboratory of Extracorporeal Circulation Devices,Guangzhou Biomedical Blood Purification Materials Research and Development Key Laboratory,Guangzhou 510663,China)

机构地区：[1]广东省医疗器械质量监督检验所,国家药品监督管理局体外循环器械重点实验室,广州市生物医用血液净化材料研究与开发重点实验室,广州510663

出　　处：《化学分析计量》2023年第10期57-61,共5页Chemical Analysis And Meterage

摘　　要：建立高效液相色谱法测定血液透析器中聚乙烯吡咯烷酮、N,N-二甲基乙酰胺和N-甲基吡咯烷酮三种残留物的溶出量。采用超纯水作为浸提溶剂,模拟临床使用条件,在(37±1)℃的恒温水浴中对样品循环浸提6h。以乙腈-水(体积比为5∶95)作为流动相等度洗脱,采用高效液相色谱法分离和测定溶出物,检测波长为205nm。聚乙烯吡咯烷酮、N,N-二甲基乙酰胺和N-甲基吡咯烷酮的质量浓度分别在5.0~100.0、0.2~20.0、0.2~20.0μg/mL范围内与色谱峰面积具有良好的线性关系,相关系数均大于0.999,方法检出限分别为1.461、0.011、0.019μg/mL。样品加标平均回收率为95.13%~103.99%,测定结果的相对标准偏差为0.08%~0.67%(n=6)。该方法制样简单,适用于血液透析器中聚乙烯吡咯烷酮、N,N-二甲基乙酰胺和N-甲基吡咯烷酮三种残留物的溶出量测定。A method was established to determine the dissolution amount of polyvinylpyrrolidone,N,N-dimethylacetamide and N-methylpyrrolidone in hemodialyzer by high performance liquid chromatography.Water was used as the extraction solvent,the sample was cyclically extracted for 6 hours in a constant temperature water bath at(37±1)℃to simulate clinical conditions.Acetonitrile water(volume ratio was 5∶95)was used as the mobile phase for isocratic elution,and the dissolved substance was separated and determined by high performance liquid chromatography.The detection wavelength was 205 nm.The mass concentrations of polyvinylpyrrolidone,N,N-dimethylacetamide,and N-methylpyrrolidone had a good linear relationship with the chromatographic peak area in the range of 5.0-100.0,0.2-20.0 and 0.2-20.0μg/mL,respectively,the correlation coefficients were all more than 0.999,and the detection limits of the method were 1.461,0.011,0.019μg/mL,respectively.The average recovery rates of the sample were 95.13%-103.99%,and the relative standard deviations of the determination results were 0.08%-0.67%(n=6).The method has the advantages of simple sample preparation,which can be suitable for the determination of dissolution amount of polyvinylpyrrolidone,N,N-dimethylacetamide and N-methylpyrrolidone in hemodialyzer.

关 键 词：高效液相色谱法 血液透析器 聚乙烯吡咯烷酮 N N-二甲基乙酰胺 N-甲基吡咯烷酮 溶出量 

分 类 号：O657.7[理学—分析化学]