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.
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)
出处
《化学工程师》
CAS
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)。
关键词
盐酸安妥沙星片
右旋安妥沙星
对映异构体
antofloxacin hydrochloride tablets
dextral antofloxacin
enantiomer
