离子色谱法同时测定奥拉西坦注射液中微量EDTA及磷酸根离子

IC determination of trace EDTA and phosphate in oxiracetam injection

目的：建立同时测定微量EDTA及磷酸根离子的抑制型离子色谱法。方法：采用IonPac AS 11 HC（250 mm×4 mm）色谱柱和CSRSULTRAⅡ4 mm自身循环抑制器,以氢氧化钾淋洗液梯度洗脱,流速为1.0 mL·min^-1,抑制电流为59 mA,电导检测器温度35℃。结果：EDTA和磷酸根离子线性范围分别为0.15-0.51μg·mL^-1和0.75-3.51μg·mL^-1,回收率为97%-101%。结论：本方法准确、简便、快速,可用于注射液中微量EDTA及磷酸根离子的快速测定。

Objective：To develop a suppressed conductivity ion chromatography method for the determination of trace EDTA and phosphate in oxiracetam injection.Methods：Chromatographic separation was achieved on an IonPac AS 11 HC（250 mm×4 mm）column with KOH gradient elution.The flow rate was 1.0 mL·min^-1.The suppressor（ASRS ULTRA Ⅱ 4 mm）was operated at an applied current of 59 mA in the auto suppression recycle mode.The conductivity detector temperature was maintained at 35 ℃.Results：The linear ranges of EDTA and phosphate were 0.15-0.51 μg·mL^-1 and 0.75-3.51 μg·mL^-1,respectively.The recoveries of both the anion ions were between 97%-101%.Conclusion：The method is proved to be rapid,accurate,and convenient,and provides a reliable way for determination the trace EDTA and phosphate in injection products.