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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,5μm),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20μL。结果:甲磺酸浓度在1.334～13.34μg.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0.10μg.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 a method for the determination of methanesulfonic acid in olsalazine sodium by ion chromatography. Methods: Dissolve the sample with high-purity water as the test solution, and determine the content of methanesulfonic acid using ion chromatography. A Supp 7-250 anion analytical column (250 mm × 4.0 mm, 5 μm) was used with mobile phase of 3.2 mmol·L -1 sodium carbonate and 1.0 mmol·L -1 sodium bicarbonate-acetone (95: 5) 0.7 mL.min-1; injection volume 20μL. Results: The linear range of methanesulfonic acid was 1.334 ~ 13.34μg.mL-1 (r = 0.9999). The average recovery of methanesulfonic acid was 99.8% (n = 9) Limited to 0.10 μg.mL-1 (S / N = 3). Conclusion: The method can accurately determine the content of methanesulfonic acid in the raw material of olsalazine sodium and effectively control its quality.