ICP-MS同时测定注射用亚锡替曲膦中磷和锡的含量  

Determination of content of P and Sn in tetrofosmin and stannous chloride for injection by ICP-MS

作　　者：连晓芳 郭鑫 左利民[1] 姜艺菲 刘惠一 肖菁 姚静 山广志[1] LIAN Xiaofang;GUO Xin;ZUO Limin;JIANG Yifei;LIU Huiyi;XIAO Jing;YAO Jing;SHAN Guangzhi(Analysis and Testing Center of Institute of Medicinal Biotechnology,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100050,China;Institute for Biosafety,Hunan Institute for Drug Control,Changsha 410001,China;Antitumor and Radiopharmaceutical Laboratory of Chemical Drug Testing,Institute for the Control of Chemical Drugs,National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国医学科学院北京协和医学院医药生物技术研究所分析测试中心,北京100050 [2]湖南省药品检验检测研究院生物安全所,长沙410001 [3]中国食品药品检定研究院化学药品检定所抗肿瘤与放射药品室,北京102629

出　　处：《中国医药生物技术》2025年第1期89-94,共6页Chinese Medicinal Biotechnology

基　　金：中国食品药品检定研究院化学药品检定所学科建设课题(2023HYZX30,2024HYZX33);湖南省自然科学基金科药联合基金(2022JJ80071)。

摘　　要：目的建立一种通过同时测定注射用亚锡替曲膦中磷(P)和锡(Sn)元素含量计算替曲膦和氯化亚锡含量的电感耦合等离子体质谱(ICP-MS)方法。方法通过2%硝酸溶解、超声、离心等简单的前处理,使用ICP-MS对注射用亚锡替曲膦中两种元素进行测定。ICP-MS的采集模式选择动能歧视(KED)模式,P的测定以钒为内标,Sn的测定以锑为内标,重复采样三次取平均值。结果方法学验证显示,P和Sn在0~10μg/mL浓度之间与其相对应的计数值呈现良好的线性关系,相关系数(r)分别为1.000和0.9999,P的定量限和检测限分别为3.073×10^(-2)μg/mL和1.014×10^(-2)μg/mL,Sn的定量限和检测限分别为9.850×10^(-4)μg/mL和3.251×10^(-4)μg/mL,P和Sn元素的加标回收率分别为101.0%和100.3%,RSD分别为5.35%(n=9)和4.68%(n=9)。结论ICP-MS法简便、快速,能够较好满足注射用亚锡替曲膦中氯化亚锡和替曲膦含量测定的要求。Objective An inductively coupled plasma mass spectrometry(ICP-MS)method was developed for calculating the content of tetrofosmin and stannous chloride by simultaneously determining P and Sn content in tetrofosmin and stannous chloride for injection.Methods The elementals were determined by ICP-MS using simple pre-treatment processes such as 2%nitric acid dissolution and ultrasonic centrifugation.The acquisition mode of ICP-MS was selected as kinetic energy discrimination(KED)mode,and vanadium was used as internal standard for phosphorus determination,and antimony was used as internal standard for Sn determination,and the sampling was repeated three times to take the average value.Results Methodological verification indicated that the calibration curves showed good linearity between the concentrations of 0~10μg/mL and their corresponding counting values for both P and Sn,with the correlation coefficients(r)of 1.000 and 0.9999,respectively.The limits of quantitation and detection of P were 3.073×10^(-2)μg/mL and 1.014×10^(-2)μg/mL,respectively.The limits of quantitation and detection of Sn were 9.850×10^(-4)μg/mL and 3.251×10^(-4)μg/mL,respectively.The recoveries of P and Sn were 101.0%and 100.3%,respectively,and the RSD were 5.35%(n=9)and 4.68%(n=9),respectively.Conclusions The ICP-MS method is simple and rapid.It can better meet the requirements for the determination of stannous chloride and the tetrofosmin in tetrofosmin and stannous chloride for injection.

关 键 词：电感耦合等离子体质谱法 替曲膦 氯化亚锡 动能歧视模式 

分 类 号：R927.2[医药卫生—药学]