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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,5μm)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1.0mL·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0.5074~507.444μg·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0.16μg·mL-1(S/N≥10),检测限分别为0.05μg·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: To establish a method for the determination of antioxidants in injection by ion chromatography inhibition conductivity method. METHODS: The gradient elution was performed with anion exchange column AG-11HC guard column and AS11-HC analytical column (250 mm × 4 mm, 5 μm) using potassium hydroxide solution as eluent. The suppressor current was set at 149 mA , The flow rate of 1.0mL · min-1, conductivity detector for the determination of the total amount of sodium sulfite injection. Results: The calibration curves of sodium sulfite in the range of 0.5074 ~ 507.444μg · mL-1 were linear with the correlation coefficients of 0.9998 (n = 5) and the limits of quantification of 0.16μg · mL-1 (S / N≥10) Respectively, 0.05μg · mL-1 (S / N≥3). Conclusion: The method has high selectivity, good sensitivity and accurate determination results. It can be used in the determination of antioxidants in injection.