非水电位滴定法测定盐酸精氨酸含量方法的改进  

Optimization for the determination method of arginine hydrochloride by non-aqueous potentiometric titration

作　　者：田甜 胡艳霞 江燕 柳艳云 TIAN Tian;HU Yanxia;JIANG Yan;LIU Yanyun(Hubei Institute for Drug Control,Wuhan 430075,China;Hubei E′zhou Public Inspection and Testing Center,E′zhou 436000,China;Hubei Engineering Research Center for Drug Quality Control,Wuhan 430075,China)

机构地区：[1]湖北省药品监督检验研究院,武汉430075 [2]湖北省鄂州市公共检验检测中心,湖北鄂州430075 [3]湖北省药品质量检测与控制工程技术研究中心,武汉430075

出　　处：《中国药品标准》2022年第2期206-209,共4页Drug Standards of China

基　　金：国家药典委员会药品标准制修订研究课题(课题编号:2020Y023)。

摘　　要：目的:改进《中国药典》2020年版二部中盐酸精氨酸含量测定的方法。方法:采用电位滴定法,以冰醋酸为溶剂,革除现行标准中醋酸汞的使用,建立了测定盐酸精氨酸含量的方法。结果:改进后的方法空白溶液不干扰测定,供试品溶液在5h内稳定;方法的精密度为99.66%(RSD=0.28%,n=9),准确度良好,测定值与真实值相对偏差为0.4%。改进后方法含量测定结果与药典方法测定结果无显著性差异。结论:改进后的方法不但革除了汞盐的使用,且操作简便、快速,精密度与准确度良好,适用于盐酸精氨酸样品的含量测定。Objective:To improve the method for the determination of arginine hydrochloride in the Chinese pharmacopoeia 2020 volume II.Methods:The new determination method of arginine hydrochloride was established with non-aqueous potentiometric titration.Glacial acetic acid was used as the solvent to eliminate the use of mercury acetate in the current standard.Results:The blank solution of the improved method did not interfere with the determination,and the test solution was stable within 5 h.The precision of the method was 99.66%(RSD=0.28%,n=9),the accuracy was good,and the relative deviation between the measured value and the real value was 0.4%.There was no significant difference between the improved method and the pharmacopoeia method.Conclusion:The improved method not only eliminates the use of mercury salt,but also has the advantages of simple and rapid operation,good precision and accuracy.It is suitable for the determination of arginine hydrochloride.

关 键 词：盐酸精氨酸 含量测定 非水电位滴定 醋酸汞 

分 类 号：R921.2[医药卫生—药学]