ICP-OES法同时测定门冬氨酸钾镁注射液中钾离子和镁离子的含量

目的：建立电感耦合等离子体原子发射光谱（ICP-OES）法同时测定门冬氨酸钾镁注射液中钾离子和镁离子的含量。方法：根据专属性高、干扰小的原则，分别选择766.490 nm和279.553 nm作为钾和镁的分析谱线，建立ICP-OES法同时测定门冬氨酸钾镁注射液中钾离子和镁离子的含量。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。采用新建的ICP-OES法与传统的滴定法和重量法分别对来源于2个厂家的5批样品同时进行测定和统计学分析。结果：钾离子和镁离子的线性范围分别为5~25 μg·mL^-1（r²=0.999 1）、1~9 μg·mL^-1（r²=0.999 5）；钾离子和镁离子高、中、低3种浓度的回收率分别在98.3%~100.0%和98.5%~101.5%，RSD分别为0.6%（n=9）和0.9%（n=9）。5批样品的测定结果经t检验统计分析，统计结果p>0.05，表明ICP-OES法与传统测定方法无显著性差异，可以替代传统方法进行钾离子和镁离子的含量测定。结论：所建立的ICP-OES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 method for simultaneous determination of the content of principal ions K⁺ and Mg²⁺ in the potassium aspartate and magnesium aspartate injection by inductively coupled plasma-atomic emission spectrometry (ICP-OES).Methods: An ICP-OES method was established to determine the content of K⁺ and Mg²⁺ in the potassium aspartate and magnesium aspartate injection.Based on the principle of specificity and interference,766.490 nm and 279.553 nm were selected as the analytical spectral lines for K⁺ and Mg²⁺,respectively.And the established method was proved by methodology validation such as specificity,precision,recovery and linearity.Finally,5 batches of samples which derived from two factories were determined by the established ICP-OES method and the conventional methods such as titration method and weight method.The results were statistically analyzed.Results: The calibration curve was linear over the range of 5-25 μg·mL^-1(r²=0.999 1)for K⁺、1-9 μg·mL^-1(r²=0.999 5) for Mg²⁺.The recoveries of K⁺ were between 98.3% and 100.0% at high-medium and low concentrations,while those of Mg²⁺ were between 98.5% and 101.5%.The relative standard derivations of K⁺ and Mg²⁺ were 0.6% (n=9) and 0.9% (n=9),respectively.The results of the five batches of samples showed p>0.05 which were analyzed by t test.The data indicated that ICP-OES method and the traditional method had no significant differences,and the established ICP-OES method could be used to replace the traditional method.Conclusion: The established ICP-OES method is proved by methodology validation.It is convenient,specific,accurate and rapid.It has the characteristics of simultaneous multi-element determination and it is suitable for the analysis of batches of samples.And it is applicable for the quality control of potassium aspartate and magnesium aspartate injection.