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
陈华燕，黄麒谕，徐苏华
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
Determination of the dissolution amount of polyvinylpyrrolidone, N, N-dimethylacetamide and N-methylpyrrolidone from hemodialyzer by high performance liquid chromatography
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
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 6 h。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 205 nm。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、0.2～20.0 μg/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、0.019 μg/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。
Abstract：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 0.2-20.0 μg/mL, respectively, the correlation coefficients were all more than 0.999, and the detection limits of the method were 1.461, 0.011, 0.019 μg/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
Keywords：high performance liquid chromatography; hemodialyzer; polyvinylpyrrolidone; N, N-dimethylacetamide;N-methylpyrrolidone; dissolution amount
本文引用格式：
陈华燕，黄麒谕，徐苏华.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[J].
化学分析计量，2023，32(10)：57.CHEN Huayan，HUANG Qiyu，XU Suhua. Determination of the dissolution amount of polyvinylpyrrolidone，N，N-dimethylacetamideand N-methylpyrrolidone from hemodialyzer by high performance liquid chromatography[J]. Chemical Analysis and Meterage，2023，32(10)：57.
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