离子色谱法测定苦碟子注射液中硫酸盐和亚硫酸盐

目的: 建立测定苦碟子注射液中硫酸盐和亚硫酸盐的含量测定方法。 方法: 采用离子色谱法,测定苦碟子注射液中硫酸盐和亚硫酸盐的含量。采用美国戴安公司Ion Pac AS 18(250 mm×4.0 mm)阴离子交换色谱柱和Ion Pac AG 18(50 mm×4.0 mm)阴离子交换保护柱,淋洗液为氢氧化钾溶液,梯度淋洗,流速1.00 mL·min^-1,柱温30 ℃,进样量25 μL;加水抑制模式,抑制电流为100 mA,电导池温度35 ℃。 结果: SO₄^2-浓度在1.074~10.74 mg·L^-1范围内与其峰面积呈良好的线性关系(r=0.9962),SO₃^2-浓度在1.024~10.24 mg·L^-1范围内与其峰面积呈良好的线性关系(r=0.9954);SO₄^2-平均加样回收率(n=6)为99.1%(RSD=0.78%),SO₃^2-平均加样回收率(n=6)为91.8%(RSD=0.49%)。 结论: 该方法操作简单,结果准确,灵敏度高,重复性好,可作为控制苦碟子注射液中硫酸盐和亚硫酸盐的方法。

Objective: To establish a method to determination sulfate and sulfite in Kudiezi injection by ion chromatography. Methods: The content of sulfate and sulfite was measured by ion chromatography,a column of Ion Pac AS 18(250 mm×4.0 mm) and Ion Pac AG 18(50 mm×4.0 mm) were adopted,potassium hydroxide solution was used as eluent at a flow rate of 1.00 mL·min^-1,and the column temperature was set at 30 ℃;water suppression mode,detected in 100 mA suppressed current,and the detection cell temperature was set at 35 ℃. Results: Under the regulated condition,there was a good linear relationship in the ranges of 1.074-10.74 mg·L^-1 for SO₄^2-(r=0.9962) and 1.024-10.24 mg·L^-1 for SO₃^2-(r=0.9954);The average recoveries(n=6) were 99.1%(RSD=0.78%) and 91.8%(RSD=0.49%). Conclusion: This method is simple,sensitive,reproducible,and accurate for determination of sulfate and sulfite in Kudiezi injection.

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