氨咖黄敏胶囊中马来酸氯苯那敏含量及含量均匀度测定  

Determination of Content and Uniformity of Chlorphenamine Maleate in Ankahuangmin Capsules by HPLC

作　　者：吴珺 吴虹萍 

机构地区：[1]江苏省泰州市药品检验所,江苏泰州225300 [2]江苏省兴化市第四人民医院,江苏兴化225741

出　　处：《中国药业》2008年第9期32-33,共2页China Pharmaceuticals

摘　　要：目的建立高效液相色谱(HPLC)法,测定氨咖黄敏胶囊中马来酸氯苯那敏含量及含量均匀度。方法采用AgilentC18柱(150mm×4.6mm,5μm),以甲醇-0.01mol/L磷酸二氢钾-0.02mol/L庚烷磺酸钠(58.5∶35.5∶6)为流动相,流速为1mL/min,检测波长为215nm,柱温为25℃。结果马来酸氯苯那敏质量浓度在11.99～47.98μg/mL(r=0.9998)范围内与峰面积线性关系良好,平均加样回收率为99.17%,RSD=0.2%(n=6)。结论HPLC法简便、快速,重现性良好。Objective To establish the HPLC method for the content and uniformity of chlorphenamine maleate in Ankahuangmin Capsules. Methods Agilent C18 column （150 mm ×4. 6 mm, 5μm） was used. The mobile phase was methanol-0. 01 mol/L monopotassium phosphate - 0.02 mol/L 1 -heptane sulfonic acid sodium salt （58.5 ： 35.5 ： 6）. The flow rate was 1 mL/min. The detection wavelength was 215 nm and the column temperature was 25 ℃. Results The linear range of chlorphenamine maleate was 11.99-47.98 μg/mL（ r =0. 999 8）. The average recovery rate was 99.17% , RSD = 0. 2% （ n = 6）. Conclusion The method is simple, quick and precise.

关 键 词：高效液相色谱法 氨咖黄敏胶囊 马来酸氯苯那敏 含量 含量均匀度 

分 类 号：R927.2[医药卫生—药学] R971.1