离子色谱法测定注射剂中的抗氧剂亚硫酸钠

目的: 建立离子色谱抑制电导法测定注射剂中的抗氧剂含量的方法。 方法: 采用阴离子交换柱AG-11HC保护柱和 AS11-HC分析柱(250 mm×4 mm,5 μm)以氢氧化钾溶液作淋洗液,进行梯度洗脱,抑制器电流值设定为149 mA,流速为1.0 mL·min^-1,电导检测器测定注射剂中亚硫酸钠的总量。 结果: 亚硫酸钠在0.5074~507.444 μg·mL^-1浓度范围内线性关系良好,相关系数分别为0.9998(n=5);定量限分别为0.16 μg·mL^-1 (S/N≥10),检测限分别为0.05 μg·mL^-1 (S/N≥3)。 结论: 本方法选择性高,灵敏度好,测定结果较为准确,可用于注射剂中抗氧剂的测定研究。

Objective: A suppressed conductivity ion chromatography method was established for determination of antioxidant in injections. Method: The AG-11HC anion guard column and the AS11-HC anion analytical column(250 mm×4 mm,5 μm)was employed to separate and determinate the sodium sulfite with the eluent of KOH using the gradient mode.The flow was 1.0 mL·min^-1,and the suppressed currentset was 149 mA with conductivity detector. Results: Good linear relationship was established between the peak response and the concentration of 0.5074-507.444 μg·mL^-1with the quantitation limit (S/N=10) of 0.16 μg·mL^-1,and the detection limit (S/N=3) of 0.05 μg·mL^-1. Conclusion: The proposed method shows high selectivity,sensitivity and good results.It can be employed for the quality control and research of antioxidants in injections.

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