摘要
建立电感耦合等离子体发射光谱法(ICP-OES)测定卡巴他赛注射液与输液装置相容性试验中镁和铝的含量。采用微波消解法处理样品,分别以280.270和396.153 nm作为ICP-OES测定镁和铝含量的分析谱线。结果显示,镁和铝的质量浓度均在0.02~1μg·mL^(-1)范围内与相应的响应强度呈良好的线性关系,R分别为0.99999和0.99995,检测下限分别为0.00009和0.004μg·mL^(-1),平均回收率(n=9)均在86.3%~101.8%。3批0.9%氯化钠注射液-卡巴他赛注射液铝元素含量均小于定量限,镁元素含量均小于0.007μg/mL;3批5%葡萄糖注射液-卡巴他赛注射液铝元素均未检出(检出限为0.004μg/mL),镁元素含量均小于0.001μg/mL。该方法灵敏度高、准确好,适用于甲卡巴他赛注射液与输液装置相容性试验中镁和铝的含量检测。
To establish a method for simultaneous determination of magnesium and aluminium in cabazitaxel injection by inductively coupled plasma emission spectrometry(ICP-OES)method.The sample was digested by microwave and determined by ICP-OES using analytical lines of elements of 280.270 nm for magnesium and 396.153 nm for aluminium.The concentration of magnesium and aluminium in the range of 0.02~1μg·mL^(-1)showed a good linear relationship with the R of 0.99999 and 0.99995,respectively,and the detection limits were 0.00009 and 0.004μg·mL^(-1),respectively,and average recoveries were 86.3%~101.8%.In the three batches of samples with 0.9%sodium chloride injection,the contents of aluminium were all less than LOQ,and the contents of magnesium were all less than 0.007μg·mL^(-1).In the three batches of samples with 5%glucose injection,the contents of aluminium were all less than LOD,and the contents of magnesium were all less than 0.001μg·mL^(-1).The method is highly sensitive accurate and reliable,and can be used for the determination of magnesium and aluminium content in compatibility test of cabazitaxel injection and infusion device.
作者
陈江
刘妮妮
张青
张海梅
黄青玲
强文舟
耿少敏
CHEN Jiang;LIU Nini;ZHANG Qing;ZHANG Haimei;HUANG Qingling;QIANG Wenzhou;GENG Shaomin(Department of Pharmacy,Shaanxi Provincial Armed Police Corps Hospitsl,Xi′an 710054,China;Xi′an Xintong Pharmaceutical Research Co.,Ltd.,Xi′an 710077,China)
出处
《山东化工》
2025年第15期136-139,143,共5页
Shandong Chemical Industry
