HPLC法测定注射用亚锡甲氧异腈中MIBI含量的方法学研究  

A Methodological Study on the Determination of MIBI in Methoxy Isobutyl Isonitrile and Stannous Chloride for Injection by HPLC Method

作　　者：刘倩楠 李英 梁塑 王勇 王玉玺 范振亚 姜华 程缤雁 李岩 杨柳 LIU Qiannan;LI Ying;LIANG Su;WANG Yong;WANG Yuxi;FAN Zhenya;JIANG Hua;CHENG Binyan;LI Yan;YANG Liu(High Tech.of Atom 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5期910-916,共7页Labeled Immunoassays and Clinical Medicine

摘　　要：目的建立高效液相色谱法测定注射用亚锡甲氧异腈中四(2-甲氧异腈)络铜(I)氟硼酸盐(MIBI)含量的方法。方法采用Agilent ZORBAX 300ASCX色谱柱(4.6mm×250mm,5μm),以乙腈-20.4g/L磷酸二氢钾(稀磷酸调pH至4.0)(V∶V=40∶60)为流动相,使用紫外检测器(检测波长为230nm),柱温为20℃,以1.0mL/min的流速进行等度洗脱,运行10min。结果采用该方法,MIBI在50~200μg/mL浓度范围内线性关系良好(r=0.9992),回收率为92%~105%,RSD为1.31%,耐用性和精密度良好。结论该方法专属性强、线性范围广、准确度高、稳定性好,可用于注射用亚锡甲氧异腈中MIBI的含量测定,为制定该类药物的质量控制标准提供了技术参考。Objective To develop a HPLC method for the determination of Copper Tetra-MIBI Tetraluoroborate(MIBI)in methoxy isobutyl isonitrile and stannous chloride for injection.Methods Agilent ZORBAX 300A SCX column(4.6mm×250mm,5μm)was used in this study.Acetonitrile-20.4g/L potassium dihydrogen phosphate(adjusted to pH 4.0 by dilute phosphoric acid)was used as the mobile phase,and UV detector(Wavelength was 230nm),with a flow rate of 1.0mL/min,and isocratic elution method were used for the analysis.Results The linear relationship of MIBI was good in the concentration range of 50-200μg/mL(r=0.9992).The recovery rate was 92%-105%,and RSD was 1.31%.The durability and precision were both good.Conclusion The method developed in this study are evaluated for its specificity,linearity,accuracy and stability,and it can be used to determine the content of MIBI in methoxy isobutyl isonitrile and stannous chloride for injection,which provides technical references for establishing the quality control standard of this type of drugs.

关 键 词：注射用亚锡甲氧异腈 高效液相色谱法 含量测定 方法验证 

分 类 号：R-331[医药卫生]