容量滴定法测定去羟肌苷含量的分析方法验证与认可  

Methodological verification and approval of the volumetric titration determination of didanosine

作　　者：连莹[1] 仲平[1] 

机构地区：[1]河南省食品药品检验所,郑州450003

出　　处：《药物分析杂志》2015年第6期1110-1114,共5页Chinese Journal of Pharmaceutical Analysis

基　　金：中国全球基金TB结核病项目卫生系统加强(HSS)药品质量标准提高项目(2010-2013)

摘　　要：目的:建立容量滴定法测定去羟肌苷的含量。方法:采用非水溶液滴定法,以冰醋酸-醋酐混合溶液(4∶1)为滴定介质,电位滴定指示终点,每次加液体积为0.05 m L,等当点突跃幅度EPC设定为30,进行含量测定,并对分析方法进行验证,具体阐述了容量滴定法的方法验证过程和验证结果的认可标准。结果:去羟肌苷测定的成比例系统误差、额外系统误差及精密度均符合规范要求。结论:本法经方法学验证,可用于去羟肌苷原料的含量测定。Objective：To establish a volumetric titration method for determination of didanosine.Methods：The non-water determination method was established for the content of didanosine with 40 m L glacial acetic acid and 10 m L anhydride acetic acid as the titration medium,the end point was determined potentiometrically,the volume step was 0.05 m L and EPC was set at 30.The established method was used for content determination and the analytical method was verified.The procedures and approval criteria of volumetric titration for determination of didanosine was described in this article.Results：The good proportional systematic,the additional proportional systematic and the statistical error acquired in this method met the requirement of related standards.Conclusion：It is proved that the method can be applied for the determination of dianosine by the methodology validation.

关 键 词：去羟肌苷 核苷类逆转录酶抑制剂 双去氧三磷酸腺苷(dd ATP) 容量滴定法 电位滴定 方法验证 

分 类 号：R917[医药卫生—药物分析学]