高效液相色谱法测定血液透析器中N-甲基吡咯烷酮

Determination of N-methylpyrrolidone in hemodialyzer by high performance liquid chromatography

建立高效液相色谱法测定血液透析器中N-甲基吡咯烷酮溶出量的分析方法。以超纯水为替代溶剂,模拟临床使用条件循环浸提5 h。采用XSelect HSS T3柱为分析柱,乙腈–磷酸盐缓冲溶液(体积比为3∶97)为流动相洗脱,检测波长为200 nm。N-甲基吡咯烷酮质量浓度在0.054 08~21.63 μg/mL范围内与色谱峰面积的线性关系良好,线性相关系数为0.999 9。测定结果的相对标准偏差为0.086%~1.332%(n=6),加标回收率为93.12%~95.13%。该方法可测定血液透析器中N-甲基吡咯烷酮的溶出量,以评估血液透析器的安全风险。

A method for the determination of N-methylpyrrolidone dissolution in hemodialyzer by high performance liquid chromatography was established.Ultrapure water was used as alternative solvent to simulate clinical conditions for cyclic extraction for 5 hours.The high performance liquid chromatography was performed on a column of XSelect;HSS T3 by elution using acetonitrileand phosphate buffer solution(volume ratio was 3∶97) as the mobile phases,and detected by DAD detector at a wavelength of 200 nm.The mass concentration of N-methylpyrrolidone had a good linear relationship with the chromatographic peak area in the range of 0.054 08–21.63 μg/mL,the linear correlation coefficient was 0.999 9.The relative standard deviations of the determination results were 0.086%–1.332%(n=6),and the recoveries were 93.12%–95.13%.This method can determine the dissolution of N-methylpyrrolidone in hemodialyzer to evaluate the safety risk of hemodialyzer.