HPLC法测定蛋白琥珀酸铁口服溶液中防腐剂的含量

Determination of antiseptic in iron proteinsuccinylate oral solutionby HPLC

目的：建立测定蛋白琥珀酸铁口服溶液中防腐剂含量测定方法。方法采用高效液相色谱法。使用 AichromBond-AQ C18柱，流动相为乙腈—水（40∶60），流速1．0 mL·min －1；检测波长254 nm，柱温40℃。结果口服液中的防腐剂对羟基苯甲酸甲酯钠和对羟基苯甲酸丙酯钠分离完全，检测浓度的线性范围分别为0．873～8．732 mg·L －1和0．296～2．964 mg·L －1，r均大于0．999；平均回收率分别为99．1％和100．1％（RSD 均小于2．0％），精密度 RSD 分别0．04％和0．22％。结论该方法简单快捷，可用于新药蛋白琥珀酸铁口服液防腐剂的定量检测，结果准确可靠。

Objective To establish an HPLC method for content determination of antiseptic in iron proteinsuccinylate oral solution. Methods HPLC with AichromBond-AQ C18 column was adopted.The mobile phase was acetonitrile-water （40∶60）at the flow rate of 1.0 mL·min -1 ,and the detective wavelength was 254 nm.The column temperature was 40℃.Results Sodium methylparaben and sodium propyl p-hydroxybenzoate isolated completely.The calibration curves were linear in the range from 0.873 mg·L -1 to 8.732 mg ·L -1 and from 0.296 mg·L -1 to 2.964 mg·L -1 （r 〉0.999）.The average recoveries were 99.1% and 100.1% （RSD 〈2.0%）. RSDs of precision were 0.04% and 0.22% respectively.Conclusions The method is convenient and rapid,which can be used for ac-curate and reliable quantitative detection of antiseptic in iron proteinsuccinylate oral solution.