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 detection

建立一种高效液相色谱荧光法测定血液透析器中双酚A溶出量。采用密度为0.9373~0.9378 g/mL的乙醇水混合液作为浸提溶剂,模拟临床使用条件,在(37±1)℃的恒温水浴中循环浸提6 h。选择乙腈–水为流动相进行梯度洗脱。荧光检测器激发波长和发射波长分别选择227 nm和313 nm。双酚A的质量浓度在0.005~0.75μg/mL范围内与色谱峰面积线性关系良好,相关系数为0.9999。方法检出限为0.0013μg/mL。样品加标回收率为92.67%~97.87%,测定结果的相对标准偏差(RSD)为1.10%~2.66%(n=3),符合中国药典规定。所建立的方法制样简单,适用于血液透析器中的双酚A含量测定。

A high performance liquid chromatography with fluorescence detection method was established to determine the dissolution of bisphenol A in hemodialyzer.The ethanol water mixture with the density of 0.9373-0.9378 g/mL was used as the extraction solvent to simulate the clinical conditions.It was extracted in a constant temperature water bath at(37±1)℃for 6 h.Acetonitrile-water was selected as the mobile phase for gradient elution.The excitation wavelength and emission wavelength of the fluorescence detector were 227 nm and 313 nm,respectively.The mass concentration of bisphenol A had a good linear relationship with the chromatographic peak area in the range of 0.005-0.75μg/mL,and the correlation coefficient was 0.9999.The detection limit of the method was 0.0013μg/mL.The recovery of spiked samples was 92.67%-97.87%,and the relative standard deviation of the determination results was 1.10%-2.66%(n=3),which was in line with the provisions of Chinese Pharmacopoeia.The established method is simple and suitable for the determination of bisphenol A in hemodialyzer.