第一作者_离子色谱法测定奥沙拉嗪钠原料药中甲磺酸的含量

目的:建立离子色谱法测定奥沙拉嗪钠原料药中甲磺酸含量的方法。方法: 用高纯水溶解样品作为供试品溶液,使用离子色谱仪测定其中甲磺酸的含量。使用A Supp 7-250阴离子分析柱(250 mm×4.0 mm,5 μm),以3.2 mmol·L^-1碳酸钠和1.0 mmol·L^-1碳酸氢钠-丙酮(95:5)为流动相,流速0.7 mL·min^-1;进样量20 μL。结果: 甲磺酸浓度在1.334~13.34 μg·mL^-1范围内线性关系良好(r=0.9999),3个浓度水平下甲磺酸的平均回收率为99.8%(n=9),最小检出限为0.10 μg·mL^-1(S/N=3)。结论: 本法可准确测定奥沙拉嗪钠原料药中甲磺酸的含量,有效控制其质量。

Objective: To establish an ion chromatography method for the detection of methylsulfonic acid in olsalazine sodium raw medicine. Methods: The sample was resolved by high purity water to prepare the sample solution,then the content of methylsulfonic acid in the solution was measured by Metrohm IC 761 ion chromatography.The A-SUPP7-250 anion analytical column(250 mm×4.0 mm,5 μm)was used with the mixture of 3.2 mmol·L^-1 sodium carbonate and 1.0 mmol·L^-1 sodium hydrogen carbonate-acetone(95:5)as the mobile phase,the flow rate was 0.7 mL·min^-1,the injection volume was 20 μL. Results: A good linearity for the content of methylsulfonic acid was found in the range of 1.334-13.34 μg·mL^-1 with a correlation coefficient of 0.9999,the average recovery was 99.7%(n=9),the minimum detection limit was 0.10 μg·mL^-1 (S/N=3). Conclusion: The method can accurately detect methylsulfonic acid in olsalazine sodium raw medicine,and can be used as an effective method for the quality control of olsalazine sodium.

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