高效液相色谱法测定复方苯丙醇胺缓释胶囊二组分含量和溶出度  

Quantitative determination of compound phenylpropanolamine hydrochloride sustained-release capsules by HPLC

作　　者：刘洁[1] 杭太俊[1] 谢莹[2] 

机构地区：[1]中国药科大学药物分析教研室,江苏南京210009 [2]江苏省药品检验所

出　　处：《中国现代应用药学》2003年第5期409-411,共3页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的　采用反相高效液相色谱法分别测定复方苯丙醇胺缓释胶囊中两主药成分盐酸苯丙醇胺和富马酸氯马斯汀。方法　采用C18色谱柱 ,检测波长 2 15nm ,流速 1.0mL/min ,以 pH2 .5磷酸盐缓冲溶液 ( 2 .0 4 g磷酸二氢钾和 2mL三乙胺至10 0 0mL水中 ,用磷酸调pH) 甲醇 ( 85∶15 )为流动相分析苯丙醇胺 ;以相同磷酸盐缓冲溶液 甲醇 ( 70∶30 )为流动相分析富马酸氯马斯汀。结果　方法回收率、重复性和线性均良好。测试溶液在 12h内稳定。测得复方盐酸苯丙醇胺缓释胶囊中盐酸苯丙醇胺在 1,2 ,4和 8h的释放量为标示量的 15 %～ 4 5 % ,35 %～ 6 5 % ,5 5 %～ 85 %和 75 %以上。结论　方法具有灵敏 ,准确 。OBJECTIVE To develop a RP HPLC method for the determination of phenylpropanolamine hydrochloride and clemastine fumarate. METHOD The HPLC was performed on C 18 column with the mobile phases consisting of methanol pH2.5 phosphate buffer 85∶15 and 70∶30 for assay of phenypropanolamine hydrochloride and clemastine fumarate, respectively. The flow rate was 1.0 mL/min. The UV detector was set at 215nm.RESULTS The recovery and reproducibility of the assay were excellent. And the drug release of phenylpropanolamine hydrochloride were found to be more than 15%～45%?35%～65%?55%～85% and 75% at 1, 2, 4, and 8 hour respectively.CONCLUSION Two simple, sensitive, accurate, reproducible and rugged HPLC methods were developed for the assay of a compound phenylpropanolamine hydrochloride extended release capsules.

关 键 词：盐酸苯丙醇胺 富马酸氯马斯汀 高效液相色谱法 

分 类 号：R917.101[医药卫生—药物分析学] R971[医药卫生—药学]