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作 者:李智明 朱健萍 邓鸣 陈瀚 孙煜 LI Zhiming;ZHU Jianping;DENG Ming;CHEN Han;SUN Yu(Guangxi Institute for Food and Drug Control,Nanning 530021,China)
出 处:《化学分析计量》2023年第2期49-52,87,共5页Chemical Analysis And Meterage
基 金:广西壮族自治区药品监督管理局2022年药品安全科研项目(桂药监科2022-10)。
摘 要:建立电感耦合等离子体质谱(ICP-MS)法测定多西他赛注射液中17种元素(Al、As、Ba、Cd、Co、Cr、Cu、Fe、Hg、Li、Mn、Ni、Pb、Sb、Tl、V、Zn)。采用浓硝酸与过氧化氢作为消解液,经微波消解处理样品后,用ICP-MS法进行测定。Hg质量浓度在0.05~4 ng/mL范围内、其余16种元素质量浓度在0.5~40 ng/mL范围内线性关系良好,相关系数均大于0.999,各元素的检出限为0.0005~0.6 mg/kg,样品加标回收率为92.2%~108.8%,测定结果的相对标准偏差为1.1%~2.8%。该方法操作简便,线性范围宽,分析速度快,灵敏度高,可同时测定多种元素,适用于多西他赛注射液中多种元素的测定。A method was developed to determine the 17 elements including Al,As,Ba,Cd,Co,Cr,Cu,Fe,Hg,Li,Mn,Ni,Pb,Sb,Tl,V and Zn in Docetaxel injection by inductively coupled plasma mass spectrometry(ICP-MS).The sample was subjected to microwave digestion with concentrated nitric acid and hydrogen peroxide,then directly tested by ICP-MS.The linear was good for the 17 elements within the range of corresponding mass concentration of 0.5-40 ng/mL except Hg(0.05-4 ng/mL),the correlation coefficients were all more than 0.999,the detection limit was in the range of 0.0005 to 0.6 mg/kg for each element,the recovery was in the range of 92.2%to 108.8%,and the relative standard deviations of the determination results were 1.1%-2.8%.The method is an easy operated and fast method with high sensitivity and large linear range for determination of multiple elements,which is suitable for determination of multiple elements in Docetaxel injection.
关 键 词:电感耦合等离子体质谱法 多西他赛注射液 微波消解
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