EDR-ICP-MS同时测定门冬氨酸钾镁注射液中钾、镁和杂质钠的含量  

Simultaneous Determination of K^(+),Mg^(2+) and Na^(+) in Potassium Magnesium Aspartate Injection by EDR-ICP-MS

作　　者：高丽琼 彭彦 Gao Liqiong;Peng Yan(Hangzhou Institute for Food and Drug Control,Hangzhou 310022,China)

机构地区：[1]杭州市食品药品检验研究院,杭州310022

出　　处：《中国药师》2022年第10期1861-1864,共4页China Pharmacist

摘　　要：目的:测定门冬氨酸钾镁注射液中钾、镁与杂质钠含量。方法:建立电子稀释技术电感耦合等离子体质谱法(EDR-ICP-MS)同时测定门冬氨酸钾镁注射液中钾、镁和钠的含量。对所建立的方法进行专属性、精密度、回收率和线性等方法学验证。采用新建立的ICP-MS法与法定标准的滴定法和重量法分别对来源于6个厂家的29批次样品进行测定和统计分析。结果:钾、镁和钠的线性范围分别为44~70μg·ml^(-1)(r=1.0000)、16~26μg·ml^(-1)(r=1.0000)和0.5~5.0μg·ml^(-1)(r=1.0000);回收率分别为101.0%,101.4%,101.0%,RSD分别为1.3%,1.2%,0.7%(n=9)。29批次样品的测定结果经统计分析,两种测定方法测定的镁含量差异无统计学意义(P>0.05),而钾含量差异有统计学意义(P<0.05),且ICP-MS法专属性更强。钠离子含量为0.04~0.81 mg·ml^(-1),不同企业差异间含量差异较大。结论:所建立的ICP-MS法操作简单,专属性强,准确可靠、分析快速,具有多元素同时测定的特点,适合于批量样品的分析,可用于门冬氨酸钾镁注射液的质量评价和控制。Objective:To establish a content determination method for K^(+),Mg^(2+) and Na^(+) in potassium and magnesium aspartate injection by EDR-ICP-MS.Methods:An EDR-ICP-MS method was established for the simultaneous determination of K^(+),Mg^(2+) and Na^(+) in potassium and magnesium aspartate injection.The specificity,precision,recovery and linearity of the established method were verified.Totally 29 batches of samples from 6 manufacturers were analyzed respectively by the ICP-MS method,titration method and gravimetric method.Results:The linear ranges of K^(+),Mg^(2+) and Na^(+) were 44-70μg·ml^(-1)(r=1.0000),16-26μg·ml^(-1)(r=1.0000)and 0.5-5.0μg·ml^(-1)(r=1.0000),respectively;the recoveries were 101.0%,101.4%,101.0%with the RSDs of 1.3%,1.2%and 0.7%(n=9),respectively.The results of 29 batches of samples were statistically analyzed by paired t-test.The statistical results showed that there was no significant difference in the determination of Mg^(2+) (P>0.05),while there was a significant difference in the determination of K^(+)(P<0.05).Conclusion:The established EDR-ICP-MS method is simple,specific,accurate,reliable and rapid,and suitable for the analysis of batch samples,and can be used for the quality evaluation and control of potassium and magnesium aspartate injection.

关 键 词：电感耦合等离子体质谱 门冬氨酸钾镁注射液 钾 镁 钠 含量测定 

分 类 号：R927.11[医药卫生—药学]