离子色谱法测定硫酸小诺霉素中硫酸盐的含量

目的: 建立离子色谱法测定硫酸小诺霉素中硫酸盐的含量,为该类药质量控制标准提供参考。 方法: 色谱条件为:高容量氢氧化物选择性阴离子分析柱IonPac AS19(250 mm×4 mm)和IonPac AG19(50 mm×4 mm)保护柱, 20 mmol·L^-1氢氧化钾淋洗液以流速1.00 mL·min^-1等度淋洗,配有连续自动再生微膜抑制器的电导检测器。 结果: 在选定的色谱条件下,方法检出限为4.95 ng;线性范围为9.9~69.3 mg·L^-1, r=0.9992;平均加标回收率为99.2%~101.3%;精密度试验RSD为0.37%。 结论: 方法操作简单、快速,灵敏度高,结果准确,重复性好,可用于控制硫酸小诺霉素中硫酸盐的含量。

Objective: To establish a new method to analyze the sulfate content in micronomicin sulfate. Methods: Ion chromatography was performed on a separation column of IonPac AS19(250 mm×4 mm)anion exchange column with a guard column of IonPac AG19(50 mm×4 mm);20 mmol·L^-1 KOH was used as the isocratic eluent,at a flow rate of 1.00 mL·min^-1 with suppressed conductivity detection. Results: The detection limit was 4.95 ng,and the linear range of determination was 9.9-69.3 mg·L^-1 (r=0.9992).The recovery rate was 99.2%-101.3%,and the degree of precision was 0.37%,with precision test of RSD 0.82%. Conclusion: This proposed method is simple,rapid,sensitive,accurate and repeatable.