HPLC法同时测定复方环丙沙星滴鼻液中三组分的含量  

Simultaneous Determination of Three Components in Compound Ciprofloxacin Nasal Drops by HPLC

作　　者：金丽[1] 周建丽[1] 张晓丹[1] 伍小勇[1] 卜莹[1] 古卓良[1] 

机构地区：[1]南京军区联勤部药品仪器检验所,江苏南京210002

出　　处：《解放军药学学报》2014年第6期535-537,540,共4页Pharmaceutical Journal of Chinese People's Liberation Army

基　　金：军队医疗机构制剂标准提高科研专项课题;No.13ZJZ07

摘　　要：目的建立同时测定复方环丙沙星滴鼻液中盐酸麻黄碱、乳酸环丙沙星、马来酸氯苯那敏含量的HPLC方法。方法采用：PurospherSTAR RP-18色谱柱（4.6 mm×150 mm,5μm）,以磷酸盐缓冲液（p H 3.0±0.1）-乙腈（82∶18）为流动相,调节流速为1.0 ml·min-1,在210 nm波长处同时检测3组分。结果盐酸麻黄碱、乳酸环丙沙星和马来酸氯苯那敏分别在20.14~161.12、12.05~96.38和6.18~49.47μg·ml-1浓度范围内线性关系良好,相关系数分别为0.9996、0.9999和0.9999,平均回收率分别为101.11%、99.83%和101.07%。结论该方法快速简便、重复性、耐用性好,可用于该制剂中3组分的测定。Objective To establish a method for simultaneous determination of three components in compound ciprofloxacin nasal drops by HPLC.Methods HPLC was performed on a column of Purospher STAR RP-18（4.6 mm × 150 mm,5 μm） with the mobile phase composed of acetonitrile-potassium dihydrogen phosphate buffer（p H 3.0 ± 0.1）（18∶ 82 V/V） at a detection wavelength of 210 nm and a flow rate of 1.0 ml·min-1.Results A good linear relationship was established between the peak response and the concentration of ephedrine hydrochloride,ciprofloxacin lactate and chlorphenamine maleate over the range of 20.14-161.12 μg·ml-1（r = 0.9996）,12.05-96.38 μg·ml-1（r = 0.9999） and 6.18-49.47 μg·ml-1（r = 0.9999）,respectively.The mean recovery of ephedrine hydrochloride,ciprofloxacin lactate and chlorphenamine maleate was 101.11%,99.83% and101.07%,respectively.Conclusion The proposed method shows high repeatability and durability,which can be used for quality control of three components in compound ciprofloxacin nasal drops.

关 键 词：复方环丙沙星滴鼻液 HPLC 盐酸麻黄碱 乳酸环丙沙星 马来酸氯苯那敏 

分 类 号：R927.2[医药卫生—药学]