RP-HPLC法测定氯霉素滴眼液中氯霉素及二醇物的含量  

Determination of Chloramphenicol and Glycols in Chloramphenicol Eye Drops

作　　者：张雁 孙映求 王兰 

机构地区：[1]湘潭市药品检验所,湖南湘潭411100

出　　处：《中国药品标准》2005年第2期11-13,共3页Drug Standards of China

摘　　要：目的:测定氯霉素滴眼液中氯霉素和二醇物的含量。方法:采用RP- HPL C法。色谱系统:色谱柱:Krom asil ODS- 1(2 5 0×4 .6 mm)流动相为水-甲醇-冰醋酸(5 5 :4 5 :0 .1) [1 ] ,流速约为1m l·min- 1 ,检测波长为2 78nm。结果:氯霉素与二醇物的平均回收率分别为10 0 .6 %、10 0 .8% ,RSD值分别为0 .2 3%、1.4 9%。氯霉素线性范围为12 .5 μg·ml- 1～30 0 μg·ml- 1 ,二醇物线性范围为1μg·ml- 1～2 4 μg·ml- 1。结论:该法快速,简单,准确。可作为该制剂的质量控制标准。Objective:To determine the content of Chloramphenicol and Glycols in Chloramphenicol Eye Drops.Methods:A RP-HPLC method has been developed.Chromatographic system:Kromasil ODS-1(250×4.6mm).The mobile phase was water-methanol-glacial acetic acid(55:45:0.1).The flow rate was about 1ml·min -1 .The detective wavelength was 278 nm.Results:The average recovery and relative standard deviation were 100.6% and 0.23% for Chloramphenicol,100.8% and 1.49% for Glycols.The stanndard curve of Chloramphenicol was linear in the range of 12.5μg·ml -1 ～300μg·ml -1 .The stanndard curve of Glycols was linear in the range of 1μg·ml -1 ～24μg·ml -1 .Conclusions: This method is rapid,simple,accurate,and suitable for the quality control of this preparation.

关 键 词：RP-HPLC法 氯霉素滴眼液 二醇物 色谱条件 

分 类 号：R914[医药卫生—药物化学]