离子色谱法测定异甘草酸镁注射液中镁离子和钠离子的含量  

Determination of Mg^(2+)and Na^(+)in Magnesium Isoglycyrrhizinate Injection by ion chromatography

作　　者：戴冬艳 徐佳 朱静 杨宝卫[2] DAI Dongyan;XU Jia;ZHU Jing;YANG Baowei(Taizhou City Institute for Drug Control,Taizhou 225300,China;Jiangsu Food and Pharmaceutical Science College,Huaian 223003,China)

机构地区：[1]泰州市药品检验院,泰州225300 [2]江苏食品药品职业技术学院,淮安223003

出　　处：《西北药学杂志》2023年第6期54-58,共5页Northwest Pharmaceutical Journal

基　　金：江苏省高等学校基础科学(自然科学)研究重大项目(编号:22KJA350002)。

摘　　要：目的建立用离子色谱法同时测定异甘草酸镁注射液中镁离子和钠离子含量的方法。方法用阳离子交换离子色谱法,色谱柱为Dionex IonPac^(TM)CS12A RFIC^(TM)分析柱(250 mm×4 mm,8μm)和CG12A保护柱(50 mm×4 mm),淋洗液为20 mmol·L^(-1)的甲烷磺酸溶液,流速为1.0 mL·min^(-1),抑制器为Dionex CERS 500(4 mm),抑制电流为59 mA,电导检测器,柱温为30℃,进样体积为25μL。结果镁离子、钠离子质量浓度分别在0.5~10、10~100μg·mL^(-1)的范围内与其峰面积线性关系良好,相关系数分别为0.9999、0.9998;平均加样回收率分别为100.29%、101.39%(n=9),RSD值均为1.09%(n=9);精密度、重复性、稳定性实验的RSD值均小于2%(n=6)。结论所建立的离子色谱法可同时测定异甘草酸镁注射液中镁离子和钠离子的含量。Objective To establish a method for the simultaneous determination of the content of Mg^(2+)and Na^(+)in Magnesium Isoglycyrrhizinate Injection by ion chromatography.Methods The method of assay was cation exchange ion chromatography,which was performed on a Dionex IonPac^(TM)CS12A RFIC^(TM)analytical column(250 mm×4 mm,8μm)and a CG12A protective column(50 mm×4 mm).The isocratic elution was 20 mmol·L^(-1)methane sulfonic acid solution at a flow rate of 1.0 mL·min^(-1).Dionex CERS 500(4 mm)suppressor was adopted with the suppress current of 59 mA.Electrical conductivity detector was used,the column temperature was at 30℃and the injection volume was 25μL.Results Mg^(2+)and Na^(+)showed good linear relationship with the peak area in the ranges of 0.5-10μg·mL^(-1)and 10-100μg·mL^(-1),respectively.The correlation coefficients were 0.9999 and 0.9998 respectively.The average recoveries of Mg^(2+)and Na^(+)were 100.29%and 101.39%(n=9)respectively,and the RSDs were both 1.09%(n=9).The RSDs of precision,repeatability and stability tests were all less than 2%(n=6).Conclusion This established ion chromatography method can be used to determine the content of Mg^(2+)and Na^(+)in Magnesium Isoglycyrrhizinate Injection.

关 键 词：离子色谱法 异甘草酸镁注射液 含量测定 

分 类 号：R927.2[医药卫生—药学]