乳酸左氧氟沙星氯化钠注射液中氯化钠含量测定方法的探讨  

Determination of Sodium Chloride in Levofloxacin Lactate and Sodium Chloride Injection

作　　者：鄢雷娜 章红 黎忠良 陈希 肖钦钦 段和祥 YAN Leina;ZHANG Hong;LI Zhongliang;CHEN Xi;XIAO Qinqin;DUAN Hexiang(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 Jiangxi 330029,China;Jiangxi Provincial Children's Hospital,Nanchang Jiangxi 330006,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 [2]江西省儿童医院,江西南昌330006

出　　处：《药品评价》2022年第6期338-341,共4页Drug Evaluation

基　　金：江西省药品监督管理局科研项目(2019JS30)。

摘　　要：目的:建立银量法测定左氧氟沙星氯化钠注射液中氯化钠的含量。方法:以荧光黄指示液为指示剂,加入2.5%硼砂溶液调节溶液pH值,用硝酸银滴定液滴定乳酸左氧氟沙星氯化钠注射液中氯化钠的含量。结果:该方法的线性范围为3.005 25~15.026 25 mg/mL(r=0.999 9),平均回收率为100.3%,RSD为0.40%。结论:该方法简便、准确,适用于乳酸左氧氟沙星氯化钠注射液的质量控制。Objective:A silver method was established for the determination of sodium chloride in Levofloxacin sodium chloride injection.Methods:The content of sodium chloride in levofloxacin lactate sodium chloride injection was titrated with silver nitrate titrant by using fluorescent yellow indicator solution as indicator,adding 2.5%borax solution to adjust the pH value of the solution.Results:The linear range of the method was 3.00525-15.02625 mg/mL(r=0.9999).The average recovery was 100.3%,RSD was 0.40%.Conclusion:The method is simple,accurate and suitable for the quality control of levofloxacin and sodium chloride injection.

关 键 词：乳酸左氧氟沙星氯化钠注射液 氯化钠 含量测定 滴定分析法 

分 类 号：R927.2[医药卫生—药学]