EDTA滴定法测定小儿痱子粉中氧化锌的含量及方法验证  

Determination of Zinc Oxide in Baby Prickly Heat Powder by EDTA titration Method and the Method Validation

作　　者：戴冬艳 华杰 尹萌 DAI Dong-yan;HUA Jie;YIN Meng(Yangzhou Center for Food and Drug Control, Yangzhou 225009, China;Jiangsu Wande Environmental Technology Co. , Ltd. , Yangzhou 225000, China)

机构地区：[1]扬州市食品药品检验检测中心,扬州225009 [2]江苏省万德环保科技有限公司,扬州225000

出　　处：《海峡药学》2018年第5期68-71,共4页Strait Pharmaceutical Journal

摘　　要：目的建立EDTA滴定法测定小儿痱子粉中氧化锌的含量,并对此方法进行方法验证。方法利用pH=10.0的条件下,EDTA络合锌稳定的特点~[1],采用EDTA络合滴定法测定小儿痱子粉中氧化锌的含量,并参考《欧洲药典质量标准的起草技术指南》(第4版)中有关容量滴定法验证的技术要求,对此方法进行方法验证。结果氧化锌含量在20.66~80.84mg范围内与滴定液消耗体积线性关系良好(r=0.9998);低、中、高浓度样品的平均加样回收率分别为98.75%、98.00%、95.17%,RSD分别为2.6%、2.2%、2.0%;该滴定方法满足《欧洲药典质量标准的起草技术指南》(第4版)中有关容量滴定法验证的多个指标要求。结论 EDTA滴定法测定小儿痱子粉中氧化锌含量的方法可行,结果准确可靠。OBJECTIVE To establish an EDTA titration method for the determination of zinc oxide in baby prickly heat powder,and to validate the method. METHODS To use EDTA complexometric titration to determine the content of zinc oxide in baby prickly heat powder under the condition of pH = 10. 0 by utilizing the stability of ZnEDTA complex~[1]. And to validate the method by referring the technical requirements of the capacity titration verification in Technical Guide for the Elaboration of Monographs European Directorate for the Quality of Medicines Healthcare 4 th. RESULTS Zinc oxide showed good linear relation in the range of 20. 66 ~ 80. 84 mg with the titration volume（r = 0. 9998）,the average recoveries were 98. 75% 、98. 00% 、95. 17%,and RSDs were 2. 6%,2. 2%,2. 0% at low,medium and high concentrations. This titration method meets the technical requirements of the capacity titration verification in Technical Guide for the Elaboration of Monographs European Directorate for the Quality of Medicines Healthcare 4 th. CONCLUSION EDTA titration method for the determination of zinc oxide in baby prickly heat powder is feasible,accurate and reliable.

关 键 词：小儿痱子粉 氧化锌 EDTA滴定法 方法验证 

分 类 号：R927[医药卫生—药学]