HPLC法测定复方消旋山莨菪碱滴眼液中消旋山莨菪碱的含量  

Determination of Raceanisodamine in Compound Raceanisodamine Eye Drops by HPLC

作　　者：吕益涛 朱文华 蔡梅[3] 陈民辉[3] 

机构地区：[1]甘肃省白银市药品检验所,白银730900 [2]青海省海南州药品检验所 [3]江苏省药品检验所

出　　处：《中国药事》2009年第7期684-685,689,共3页Chinese Pharmaceutical Affairs

摘　　要：目的建立HPLC法测定复方消旋山莨菪碱滴眼液中消旋山莨菪碱含量。方法采用AgilentZORBAX Extend-C18色谱柱,流动相为0.02%三乙胺-甲醇（60∶40）,流速：1.0mL.min-1;检测波长：220nm。结果消旋山莨菪碱线性范围为10-100μg.mL-1（r=0.9998）;平均回收率为99.75%,RSD=1.42%（n=9）。结论该方法简便、可靠、准确,可用于该制剂的质量控制。Objective To establish a HPLC method for determination of raeeanisodamine in Compound Raceanisodamine Eye Drops. Methods The column Agilent ZORBAX Extend-C18 column was used The mobile phase consisted of 0. 02% triethylamine-methanol （60：＂ 40）. The flow rate was 1.0mL ·min. The detection wavelength was 220nm. Results The linear range of raceanisodamine was 10-100μg · mL^-1 （r=0. 9998）. The average recovery of assay was 99. 75% with RSD=1. 42% （n=9）. Conclusions This method is fast, reliable and accurate to examine and can be used to evaluate the quality of Compound Raceanisodamine Eye Drops.

关 键 词：复方消旋山莨菪碱滴眼液 消旋山莨菪碱 高效液相色谱法 

分 类 号：R971.92[医药卫生—药品] R286.0[医药卫生—药学]