电感耦合等离子体质谱法测定重酒石酸去甲肾上腺素注射液包材相容性中23种元素杂质  

Determination of the packaging compatibility of 23 elemental impurities in norepinephrine bitartrate injection by ICP-MS

作　　者：宋金红 苏庆斌 孙国祥[1] SONG Jin-hong;SU Qing-bin;SUN Guo-xiang(School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016;Beijing Yuanyan Pharmaceutical Technology Co.,Ltd.,Beijing 101102)

机构地区：[1]沈阳药科大学药学院,沈阳110016 [2]北京元延医药科技股份有限公司,北京101102

出　　处：《中南药学》2025年第1期228-233,共6页Central South Pharmacy

摘　　要：目的基于电感耦合等离子体质谱(ICP-MS)技术,建立重酒石酸去甲肾上腺素注射液包材相容性中23种元素杂质分析方法。方法样品采用一步酸稀释法,用10%(V/V)硝酸水溶液直接溶解,通过加入内标元素锗、钇、铋、碲来监控和校正分析信号的短期和长期漂移。结果空白溶液中元素的测得值均小于定量限的1/3;各元素在0.05~900μg·L^(-1)内线性关系良好(r≥0.999);各待测元素在不同加标水平的回收率均在91.50%~107.69%,RSD均在0.39%~4.6%(n=3);6份重复性溶液中元素测定结果的RSD值为0.38%~2.6%;12份溶液中元素测定结果的RSD值为0.38%~4.0%;各元素对照品溶液在室温22 h内稳定,RSD值在0.84%~4.9%。结论该方法操作简单、便捷、重现性良好、准确度较高,能有效检测出包材相容性中各元素杂质的含量,确保使用安全性。Objective To determine the compatibility of 23 elemental impurities in packaging materials for norepinephrine bitartrate injection,base on inductively coupled plasma mass spectrometry(ICPMS)technology.Methods The sample was diluted with one-step acid dilution method and dissolved directly in a 10%nitric acid aqueous solution.The short-term and long-term drift of the analysis signals was monitored and corrected by adding the internal standard elements germanium(Ge),yttrium(Y),bismuth(Bi),and tellurium(Te).Results The measured values of the elements in the blank solution were all less than one-third of the quantitative limit,the linear relationship of each element was good at 0.05~900μg·L^(-1)(r≥0.999).The recovery rates of each tested element at different spiked levels ranged 91.50%~107.69%,with relative standard deviations of 0.39%~4.6%(n=3).The relative standard deviation of element determination in 6 repeated solutions was 0.38%~2.6%.The relative standard deviation was values of element determination in 12 solutions was 0.38%~4.0%.The reference solutions of each element were stable at room temperature for 22 hours,with relative standard deviation at 0.84%~4.9%.Conclusion This method is easy to operate,convenient,and has good reproducibility.It has high measurement accuracy and can effectively detect the content of impurities in various elements in the compatibility of packaging materials.

关 键 词：注射液 包材相容性 方法学验证 元素杂质 电感耦合等离子体质谱法 

分 类 号：R927[医药卫生—药学]