摘要
目的:建立反相高效液相色谱测定扎鲁司特含量及其有关物质的方法。方法:采用 Alltech Alltima C_(18)柱(150 mm×4.6mm,5μm),以乙腈-0.05 mol·L^(-1)磷酸二氢钠溶液(用磷酸调节 pH3.2)(62:38)为流动相,流速为1.0 m L·min^(-1),检测波长224 nm。结果:杂质及降解产物均能与扎鲁司特基线分离;在5.02～201.00μg·mL^(-1)的浓度范围内与峰面积呈良好线性关系,r=0.9999(n=8);最低检测限为0.09ng;2种浓度水平的精密度 RSD 分别为0.19%和0.83%(n=6);含量和有关物质测定重复性试验 RSD 分别为0.22%和0.91%(n=6)。结论:本法准确、简便,适用于扎鲁司特及其有关物质的含量测定。
Objective： To establish a RP - HPLC method for determination of zafirlukast and its related substances. Method：The sample was separated by Alhech Alhima C18 column with acetonitrile -0. 05 mol · L^-1sodium dihydrogen phosphate（ adjust pH to 3.2 with phosphoric acdi） （62：38）as mobile phase, The flow rate was 1.0 mL · min^-1 and the detection wavelength was at 224 nm. Results： Its related substances could be separated from zafirlukast. The linear range of zafirlukast was 5.02 - 201.00 μg · mL^-1 , r = 0. 9999 （ n = 8 ）. The LOD was 0.09ng. The precision of two level concentration was 0.19% and 0.83% RSD（ n = 6）and the reproducibility was 0. 22% and 0. 91% RSD（ n = 6） respectively for the determination of content and related substances. Conclusion： This method is simple, accurate and suitable for the determination of zafirlukast and its related substances.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2008年第7期1156-1158,共3页
Chinese Journal of Pharmaceutical Analysis
