极谱法测定注射用亚锡甲氧异腈中氯化亚锡的含量  

The Determination of Stannous Chloride Content in Methoxy Isobutyl Isonitrilc and Stannons Chloride for Injection by Polarography Method

作　　者：崔晓艳 王玉玺 杨佳宁 王勇 程缤雁 姜华 刘倩楠 张明艺 范振亚 吴一凡 李岩 杨柳 CUI Xiaoyan;WANG Yuxi;YANG Jianing;WANG Yong;CHENG Binyan;JIANG Hua;LIU Qiannan;ZHANG Mingyi;FAN Zhenya;WU Yifan;LI Yan;YANG Liu(HTA Co.,Ltd.,Beijing 102413,China)

机构地区：[1]原子高科股份有限公司,北京102413

出　　处：《标记免疫分析与临床》2024年第11期2030-2035,2040,共7页Labeled Immunoassays and Clinical Medicine

摘　　要：目的建立注射用亚锡甲氧异腈中氯化亚锡含量的测定方法。方法采用经氮气饱和的0.2mol/L硝酸溶液作为稀释剂,甩汞电极(SMDE)操作模式,以极谱仪从-0.22 V起扫,在电极电位为-0.22~-0.50 V范围内记录极谱峰高,采用标准加入法测定注射用亚锡甲氧异腈中氯化亚锡的含量,并进行方法学验证。结果方法学验证结果表明,新建立的方法专属性良好,稀释剂和辅料成分在氯化亚锡出峰位置处无干扰,方法线性良好(Y=0.9644 X+2.6993,r=0.9997),平均回收率(n=6)为102.0%(RSD=2.2%),精密度的RSD为0.8%,注射用亚锡甲氧异腈溶解后在30min内测定比较稳定,相对误差小于3.0%。结论建立的极谱法灵敏、准确,可用于注射用亚锡甲氧异腈中氯化亚锡含量的准确测定,为《中国药典》标准的增订提供了可靠的方法。Objective To establish a polarography method for the determination of stannous chloride in methoxy isobutyl isonitrilc and stannons chloride for injection.Methods 0.2mol/L nitric acid solution saturated with nitrogen was used as diluent.The operation mode of mercury dump electrode(SMDE)was adopted.The polarograph started scanning from-0.22 V and recorded the height of the polarographic wave in the electrode potential range of-0.22 V to-0.50 V.The standard addition method was used to measure the content of stannous chloride in methoxy isobutyl isonitrilc and stannons chloride for injection.The methodology validation was then conducted.Results The results of methodology validation showed that the newly developed method had a good specificity,while the diluent and accessories ingredients had no interference at the peak position of stannous chloride.The method had a good linearity:Y=0.9644 X+2.6993(r=0.9997).The average recovery(n=6)was 102.0%(RSD=2.2%).RSD of precision was 0.8%.The methoxy isobutyl isonitrilc and stannons chloride for injection was relatively stable in 30 minutes after dissolution,and the relative error was less than 3.0%.Conclusion The newly developed polarography method is sensitive and accurate,and can be used for the accurate determination of methoxy isobutyl isonitrilc and stannons chloride for injection.This study provides a reliable tool for updating the pharmacopoeia standards.

关 键 词：注射用亚锡甲氧异腈 氯化亚锡 极谱法 SMDE模式 标准加入法 

分 类 号：R979.9[医药卫生—药品]