中国药事
中國藥事
중국약사
CHINESE PHARMACEUTICAL AFFAIRS
2015年
1期
45-48
,共4页
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
電感耦閤等離子體髮射光譜%碳痠鋰%雜質元素%鈣%鈉%鉀%鎂%鐵%鋁
전감우합등리자체발사광보%탄산리%잡질원소%개%납%갑%미%철%려
inductive couple plasma-atomic emission spectrometer%lithium carbonate%impurity elements%calcium%sodium%potassium%magnesium%iron%aluminum
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·mL-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。
目的：建立電感耦閤等離子體髮射光譜（ICP-AES)同時測定碳痠鋰原料藥中6種雜質元素（鈣、鈉、鉀、鎂、鐵和鋁）的分析方法，併分析不同廠商碳痠鋰原料藥的雜質含量。方法：用硝痠溶解樣品， ICP-AES法分析樣品中6種雜質元素的含量。結果：6種元素標準麯線的相關繫數均高于0.999，加標迴收率為93%～99%，檢齣限為0.0003～0.1275μg·mL-1，RSD值均小于2%；利用本法對5箇廠傢使用的碳痠鋰原料藥進行測定，結果錶明C廠的原料藥中鈣、鈉、鎂、鐵和鋁元素含量均高于其餘4箇廠傢，其中鈉超齣瞭藥典規定限度。結論：與《中國藥典》中碳痠鋰原料藥雜質測定方法進行比對，本試驗所建立的方法測定結果與藥典方法一緻，且方法專屬性彊、靈敏度高、操作簡單，可以用于碳痠鋰原料藥中6種雜質元素的測定。
목적：건립전감우합등리자체발사광보（ICP-AES)동시측정탄산리원료약중6충잡질원소（개、납、갑、미、철화려）적분석방법，병분석불동엄상탄산리원료약적잡질함량。방법：용초산용해양품， ICP-AES법분석양품중6충잡질원소적함량。결과：6충원소표준곡선적상관계수균고우0.999，가표회수솔위93%～99%，검출한위0.0003～0.1275μg·mL-1，RSD치균소우2%；이용본법대5개엄가사용적탄산리원료약진행측정，결과표명C엄적원료약중개、납、미、철화려원소함량균고우기여4개엄가，기중납초출료약전규정한도。결론：여《중국약전》중탄산리원료약잡질측정방법진행비대，본시험소건립적방법측정결과여약전방법일치，차방법전속성강、령민도고、조작간단，가이용우탄산리원료약중6충잡질원소적측정。
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 coefifcients of standard curves of six elements were higher than 0.999, the recoveries of standard addition were 93%-99%, the detection limits were 0.0003-0.1275μg·mL-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 speciifcity, high sensitivity, and simple operation, which can be used for the determination of six impurity elements in lithium carbonate raw material.
