HPLC法测定氯霉素滴眼液中苯扎溴铵含量  

Determination of Benzalkonium Bromide in Chloramphenicol Eye Drops by HPLC

作　　者：陈国旗[1] 王静[2] 易大为[1] 

机构地区：[1]辽宁省食品药品检验所,沈阳110023 [2]沈阳市铁西区中心医院,沈阳110021

出　　处：《中国药品标准》2014年第2期115-117,共3页Drug Standards of China

摘　　要：目的：建立HPLC测定氯霉素滴眼液中苯扎溴铵含量的方法。方法：采用苯基硅烷键合硅胶为固定相；流动相为0.05 moL· L^-1磷酸二氢钾溶液（用三乙胺调节pH值至5.5）-乙腈（40∶60）；检测波长220 nm；流量1.2 mL· min^-1；柱温40℃；进样量20μL。结果：苯扎溴铵在0.0304～1.218μg范围内呈良好的线性关系（r＝0.9998）；检测限为3.45 ng，定量限为6.9 ng；平均回收率为99.8％（n＝9），RSD＝1.5％。结论：该方法准确、可靠，可有效控制氯霉素滴眼液中苯扎溴铵的含量。Objective：To establish an HPLC method for the determination of benzalkonium bromide in chloramphenicol eye drops .Methods：Phenyl silane bonded silica gel was adopted as stationary phase with a mixture of 0.05 moL· L^-1 potassium dihydrogenphosphate solution （triethylamine adjusted pH to 5.5 ） and acetonitrile （40∶60） as mobile phase at the flow rate 1.2 mL· min^-1.The detecting wavelength was set at 220 nm, the column temperature was 40 ℃and the injection volume was 20 μL.Results：A good linear relationship of benzalkonium bromide was achieved in the range of 0.0304-1.218 μg（ r=0.9998 ） ,limit of detection was 3.45 ng and limit of quantitation was 6.9 ng.The average recovery was 99.8%（n=9）,RSD=1.5%.Conciusion：The method is accurate, relia-ble and could be used to control the quality of benzalkonium bromide in chloramphenicol eye drops effectively .

关 键 词：氯霉素滴眼液 苯扎溴铵 高效液相色谱法 

分 类 号：R921.2[医药卫生—药学]