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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 method for the determination of sulfates in ionomycin sulphate by ion chromatography and to provide a reference for the quality control standards of these drugs. METHODS: Chromatographic conditions were: IonPac AS19 (250 mm × 4 mm) and IonPac AG19 (50 mm × 4 mm) guard columns with high capacity hydroxide selective anion column, 20 mmol·L-1 potassium hydroxide eluent A constant flow rate of 1.00 mL · min-1 rinse, with continuous automatic regeneration of micro-membrane suppressor conductivity detector. Results: Under the selected chromatographic conditions, the detection limit was 4.95 ng, the linear range was 9.9-69.3 mg · L-1, r = 0.9992, and the average recovery was 99.2% -101.3%. The precision test RSD 0.37%. Conclusion: The method is simple, rapid, sensitive, accurate and reproducible. It can be used to control the sulfate content of trichoderma sulfate.