HPLC法测定复方苯海拉明滴鼻剂的含量  

Determination of Compound Diphenhydramine Nasal Drops by HPLC

作　　者：张钢平[1] 余卫兵[1] 毕雪艳 李莉[1] 李晓敏[1] 

机构地区：[1]河北省邯郸市药品检验所,邯郸056001

出　　处：《中国药事》2008年第3期240-241,243,共3页Chinese Pharmaceutical Affairs

摘　　要：建立测定复方苯海拉明滴鼻剂两主药含量的高效液相色谱法。色谱柱为Shim-pack VP-ODS C18；流动相为甲醇-0．2％的三乙胺溶液（用50％磷酸溶液调pH为3．0）（52：48），检测波长为254nm；柱温为室温；流速为1mL·min^-1。盐酸苯海拉明在0．01000～0．40008mg·mL^-1（r=-0．9998，n=7），盐酸麻黄碱在0．04017-1．60672mg·mL^-1（r=0．9998,n=7）范围内呈良好线性关系；平均回收率分别为99．80％，99．77％；RSD分别为0．75％，0．51％（n=9）。本法检测快速，定量准确，可用于复方苯海拉明滴鼻剂的定量分析。A HPLC method was established for determination of Compound Diphenhydramine Nasal Drops. Stationary phase was Shim-pack VP ODS C18, mobile phase was methanol-0.2% thiethylamine solution （the pH of modile phase was adjusted to 3.0 with 50% phosphate solution） （52 ： 48）, the flow rate was 1 moL·min^-1 and column temperature was the room temperature. There was a good linear relationship, when the content of diphenhydramine and ephedrine was within the range of 0. 01000-0. 40008 mg·mL^-1 （r=0. 99984, n=7） and 0. 04017-1. 60672 mg·mL^-1 （r=0. 99982, n=7） respectively. The average recovery rate was 99. 80%（n=9, RSD=0. 75%） and 99. 77%, （n=9, RSD=0. 51%）respectively. This method is rapid and accurate. It can be used for the quality control of Compound Diphenhydramine Nasal Drops.

关 键 词：复方苯海拉明滴鼻剂 HPLC 含量 

分 类 号：R927.2[医药卫生—药学]