高效液相色谱法测定抗敏缓释片中富马酸氯马斯汀含量  

Determination of the clemastine fumarate in Kangmin extended-release Tablets by HPLC

作　　者：赵陆华[1] 杭太俊[1] 黄剑[1] 江立[1] 刘洁[1] 

机构地区：[1]中国药科大学,江苏南京210009

出　　处：《中国现代应用药学》2003年第2期142-143,共2页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的　采用HPLC法测定抗敏缓释片中富马酸氯马斯汀的含量。方法　用AlltechODS(2 50mm× 4 .6mm ,5μm)色谱柱 ,0 .0 2mol/LKH2 PO4 甲醇 (30 :70 ) ,三乙胺 1 .0mL ,H3PO4 调pH3 .5为流动相 ,检测波长 2 1 5nm。结果　富马酸氯马斯汀在 0 .42 6～ 4 .2 6μg/mL线性关系良好 ,回收率 99.51 % ,RSD为 1 .3 %。结论　本法准确可行 。OBJECTIVE To establish a HPLC method for the clemastine fumarate in Kangmin extended release tablets. METHOD An Alletch ODS column (250×4.6nm,5ц) was used with mobile phase of 0.02mol/LKH 2PO 4 Methnol (30∶70,triethlamine1.0,pH=3.5) and detected at 215nm. RESULTS the calibration curve is linear over the range 0.426～4.26μg/mL, r=0.9998. The average recovery was 99.51%. CONCLUSION The method is suitable for determination of clemastine fumarate in extended release tablets.

关 键 词：抗敏缓释片 富马酸氯马斯汀 含量测定 高效液相色谱法 质量控制 

分 类 号：R976[医药卫生—药品] R927.2[医药卫生—药学]