盐酸安妥沙星片中右旋安妥沙星的测定  

Determination of dextral antofloxacin in antofloxacin hydrochloride tablets

作　　者：陈希 鄢雷娜 刘绪平 段和祥 CHEN Xi;YAN Lei-na;LIU Xu-ping;DUAN He-xiang(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang 330029,China)

机构地区：[1]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029

出　　处：《化学工程师》2022年第3期25-27,共3页Chemical Engineer

基　　金：江西省药品监督管理局科研项目(No.2019JS15)。

摘　　要：目的建立盐酸安妥沙星片中右旋安妥沙星的测定方法。方法采用Welch Ultimate XB-C_(18)色谱柱(4.6mm×250mm,5μm),流动相:L-苯丙氨酸-硫酸铜溶液(含8mmol·L^(-1)的L-苯丙氨酸和4mmol·L^(-1)的CuSO_(4),pH值为3.5)-甲醇(80∶20),流速:1.0mL·min^(-1),检测波长:302 nm,进样量:10μL。结果安妥沙星两个对映异构体之间的分离度为5.6。右旋安妥沙星浓度在2~500μg·mL^(-1)的范围内线性关系良好,回收率为98.96%~101.57%(RSD=1.0%,n=9)。结论本方法操作简单方便,适用于盐酸安妥沙星片中右旋安妥沙星的测定。OBJECTIVE To establish suitable method for determination of dextral antofloxacin in antofloxacin hydrochloride tablets.METHODS Determination was performed on Welch Ultimate XB-C_(18) column(4.6mm×250mm,5μm)with L-phenylalanine-copper sulfate solution(containing 8 mmol·L^(-1) L-phenylalanine and 4 mmol·L^(-1) copper sulfate,the pH valve is 3.5)-methanol(80∶20)as mobile phase.Flow rate:1.0 mL·min^(-1),detection wavelength:302 nm,injection volume:10μL.RESULTS The resolution of the two enantiomers of entofloxacin was 5.6.The concentration of dextral antofloxacin had a good linear relationship in the range of 2 to 500μg·mL^(-1),and the recovery rates were 98.96%to 101.57%(RSD=1.0%,n=9).CONCLUSION This method is simple and convenient to operate,and is suitable for the determination of dextral antofloxacin in antofloxacin hydrochloride tablets.

关 键 词：盐酸安妥沙星片 右旋安妥沙星 对映异构体 

分 类 号：R917[医药卫生—药物分析学]