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目的建立离子色谱法测定硫酸依替米星注射液中抗氧剂亚硫酸钠含量的方法。方法采用DionexIonPac AS11-HC(4mm×250 mm)色谱柱,DionexIonPac AG11-HC(4 mm×50 mm)保护柱,以氢氧化钾溶液为淋洗液进行梯度淋洗,流速1.0 mL·min~(-1),抑制电流99 mA,电导检测器检测,电导池温度35℃,柱温30℃。结果亚硫酸钠在8~80μg·mL~(-1)内线性关系良好;检测限为0.02μg·mL~(-1)(S/N=3),定量限为0.09μg·mL~(-1)(S/N=10)。结论本实验建立的方法快速、准确、重现性好,有助于制剂中亚硫酸钠的用量控制。亚硫酸钠作为抗氧剂有其使用的合理性,但样品中浓度过高,其处方量尚待进一步研究降低。
Objective To establish a method for the determination of sodium sulfite antioxidant in etimicin injection by ion chromatography. Methods A Dionex IonPac AS11-HC (4 mm × 250 mm) column and a Dionex IonPac AG11-HC (4 mm × 50 mm) column were used. The column was eluted with potassium hydroxide solution at a flow rate of 1.0 mL · min ~ -1), inhibit current 99 mA, conductance detector detection, cell temperature 35 ℃, column temperature 30 ℃. Results The calibration curve was 0.02μg · mL -1 (S / N = 3) and the limit of quantification was 0.09μg · mL -1 for sodium sulfite in the range of 8 ~ 80μg · mL -1. (S / N = 10). Conclusion The method established in this experiment is rapid, accurate and reproducible. It is helpful to control the dosage of sodium sulfite in the preparation. Sodium sulfite as an antioxidant has its use of rationality, but the sample concentration is too high, the prescription amount to be further studied to reduce.