摘要
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 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.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2013年第8期1359-1361,共3页
Chinese Journal of Pharmaceutical Analysis
