摘要
建立了空心纤维血液透析器在模拟临床试验的过程中二甲基乙酰胺(DMAC)溶出的测定方法,选择水作为模拟的浸提溶液,采用高效液相色谱法(HPLC)检测DMAC的溶出量,以C18(4.6 mm×250 mm)色谱柱为分析柱,紫外检测器检测波长为200 nm。试验结果表明:DMAC在0.5~50 mg/L的线性关系良好(R2=0.999 942),且该试验方法的平均加标回收率为100.7%,检出限为0.05 mg/L。该方法具有测定简单、回收率高、稳定性好、精密度好的优点,能够对DMAC准确的定量,还可用于血液透析器中DMAC溶出量的日常监管检测。
The method for determining the dissolution amount of dimethyl acetamide(DMAC)in hollow fiber hemodialyzer during simulated clinical trials was established.Water was selected as the simulated extraction solution,high performance liquid chromatography(HPLC)was used to determine the dissolution amount of DMAC,the C18(4.6 m×250 mm)column was used as the analytical column,and the detection wavelength of the ultraviolet detector was 200 nm.The test results showed that DMAC exhibited a good linear relationship(R^(2)=0.999942)in the range of 0.5~50 mg/L,and the average standard recovery rate of this method was 100.7%with the detection limit of 0.05 mg/L.This method has the advantages of simple determination,high recovery rate,good stability,good precision,and it can accurately quantify DMAC,and it can also be used for the daily supervision and determination of DMAC dissolution amount in hemodialyzer.
作者
肖月丽
杨伟芳
徐梦瑶
于江晗
赵梦园
Xiao Yueli;Yang Weifang;Xu Mengyao;Yu Jianghan;Zhao Mengyuan(Henan Tuoren Medical Device Research Institute Co.,Ltd.,Changyuan 453400,China;Key Laboratory for Quality Evaluation of Medical Biological Protection and Implanted Device,Changyuan 453400,China)
出处
《化学推进剂与高分子材料》
CAS
2023年第5期71-74,共4页
Chemical Propellants & Polymeric Materials
关键词
空心纤维血液透析器
二甲基乙酰胺
高效液相色谱
hollow fiber hemodialyzer
dimethyl acetamide
high performance liquid chromatography
