摘要
目的:建立电感耦合等离子体发射光谱(ICP-AES)同时测定碳酸锂原料药中6种杂质元素(钙、钠、钾、镁、铁和铝)的分析方法,并分析不同厂商碳酸锂原料药的杂质含量。方法:用硝酸溶解样品,ICP-AES法分析样品中6种杂质元素的含量。结果:6种元素标准曲线的相关系数均高于0.999,加标回收率为93%~99%,检出限为0.0003~0.1275μg·m L-1,RSD值均小于2%;利用本法对5个厂家使用的碳酸锂原料药进行测定,结果表明C厂的原料药中钙、钠、镁、铁和铝元素含量均高于其余4个厂家,其中钠超出了药典规定限度。结论:与《中国药典》中碳酸锂原料药杂质测定方法进行比对,本试验所建立的方法测定结果与药典方法一致,且方法专属性强、灵敏度高、操作简单,可以用于碳酸锂原料药中6种杂质元素的测定。
Objective: To establish a method for determining six impurity elements(Ca, Na, K, Mg, Fe and Al) in lithium carbonate raw material by inductive couple plasma- atomic emission spectrometer(ICP-AES), and analyze the content of impurities in lithium carbonate raw materials of different manufacturers. Methods: The samples were dissolved with nitric acid and determined by ICP-AES. Results: The correlation coefficients of standard curves of six elements were higher than 0.999, the recoveries of standard addition were 93%-99%, the detection limits were 0.0003-0.1275 μg·m L-1, the RSD was less than 2%. The determination results of impurity elements of five manufacturers showed that the contents of Ca, Na, K, Mg, Fe and Al in the raw material of manufacturer C were higher than those of the other four manufacturers, and the content of Na was over the limit of the standard in Chinese Pharmacopoeia. Conclusion: The results of six elements are all consistent with the methods in Chinese Pharmacopoeia. What is more, the ICP-AES method has advantages of strong specificity, high sensitivity, and simple operation, which can be used for the determination of six impurity elements in lithium carbonate raw material.
出处
《中国药事》
CAS
2015年第1期45-48,共4页
Chinese Pharmaceutical Affairs
关键词
电感耦合等离子体发射光谱
碳酸锂
杂质元素
钙
钠
钾
镁
铁
铝
inductive couple plasma-atomic emission spectrometer
lithium carbonate
impurity elements
calcium
sodium
potassium
magnesium
iron
aluminum