摘要
研究建立了电感耦合等离子体质谱(ICP-MS)法测定注射用甲磺酸萘莫司他迁移液中的锂、钴、锌、砷、镉、锑、钡、铅8种基于风险控制元素含量的方法。该方法以74Ge、159Tb为内标,8种元素在1～20μg/L范围内线性良好,相关系数均大于0.9999,各元素不同浓度的平均加标回收率在87.7%～121.8%,相对标准偏差(RSD)在0.22%～2.34%,该方法可以高准确率、高效率地分析风险控制元素在注射用甲磺酸萘莫司他注射液中的迁移情况,为相关风险评估提供可靠的数据依据。
The method for the determination of lithium,cobalt,zinc,arsenic,cadmium,antimony,barium and lead in nafamostat mesylate for injection by inductively coupled plasma mass spectrometry(ICP-MS)were established.It taked 74Ge and 159Tb as internal standards.Eight elements had good linear relationships in the range of 1~20μg/L.The correlation coefficients were greater than 0.9999.The average recoveries of different concentrations were in the range of 87.7%to 121.8%.The relative standard deviations(RSDs)ranged from 0.22%to 2.34%.This method has high accuracy and efficiency,which is suitable for the determination of the migration of risk control elements in nafamostat mesylate for injection.It can provide reliable data basis for risk assessment.
作者
魏君
黄梓为
方旻
谢新艺
WEI Jun;HUANG Zi-wei;FANG Min;XIE Xin-yi(Packaging Materials and Containers Test Center of Guangdong Medical Instruments Quality Surveillance and Inspection Institute,Guangdong Guangzhou 510663)
出处
《中国医疗器械信息》
2019年第5期25-26,共2页
China Medical Device Information
