摘要
目的:建立离子色谱法测定枸橼酸氢钾钠颗粒中钠、钾和枸橼酸含量的方法。方法:钾和钠的色谱条件:采用Dionex Ion Pac CS12A色谱柱(250 mm×4.6 mm,5μm),流动相为0.02 mol·L^(-1)甲烷磺酸溶液,流速为1.0 ml·min^(-1),抑制器为CSRS 300,抑制电流为59 m A,采用抑制型电导检测器,进样量为25μl。枸橼酸的色谱条件:采用Dionex HPICE-AS1离子排斥色谱柱(250 mm×9.0 mm,7.5μm),流动相为0.015 mol·L^(-1)硫酸溶液,流速为0.6 ml·min^(-1),检测波长为220 nm,进样量为10μl。结果:钠的线性范围为0.82~82.49μg·ml^(-1)(r=0.999 9),平均回收率为98.9%,RSD为0.55%(n=9);钾的线性范围为1.38~137.89μg·ml^(-1)(r=1.000 0),平均回收率为100.5%,RSD为0.53%(n=9);枸橼酸的线性范围为0.021~10.600mg·ml^(-1)(r=1.000 0),平均回收率为99.1%,RSD为0.54%(n=9)。结论:本方法简便、快速、准确,可用于枸橼酸氢钾钠颗粒的质量控制。
Objective： To establish a method of ion chromatography for the determination of sodium, potassium and citric acid in potassium sodium hydrogen citrate granule. Methods： The chromatographic conditions for potassium and sodium were as follows： a Di- onex IonPac CS12A column （250 mm×4.6mm,5μm） , 0.02 mol L-1 methane sulfonie acid solution as the mobile phase, the flow rate of 1.0 ml min- 1, the suppressor of CSRS 300, the inhibition current of 59 mA, the inhibition type conductivity detector, and the injection volume of 25 μl. The chromatographic conditions for citrate were as follows： a Dionex HPICE-AS1 colunm （250 mm ×9.0 mm,7.5 μm） , 0. 015 mol L-lsulfuric acid solution as the mobile phase, the flow rate of 0.6 ml min-1, the detection wave- length of 220 nm and the injection volume of 10 pJ. Results ： The linear range of sodium was 0.82-82.49 μg ml - l （ r = 0. 999 9 ）, and the average recovery was 98.9% （RSD = 0.55% , n = 9）. The linear range of potassium was 1.38-137.89 μg ml-1 （ r = 1.000 0）, and the average recovery was 100.5% （RSD=0.53% , n =9）. The linear range of citric acid was 0.021-10.600 μg ml -1 （ r = 1. 000 0 ） , and the average recovery was 99.1% （ RSD = 0.54%, n = 9 ）. Conclusion： The method is simple, rapid and ac- curate, and can be used for the quality control of potassium sodium hydrogen citrate granule.
作者
朱瑜超
李苗
黄慧芬
Zhu Yuchao Li Miao Huang Huifen(Wuhan Institute for Drug and Medical Device Control, Wuhan 430000, Chin)
出处
《中国药师》
CAS
2017年第3期568-570,共3页
China Pharmacist
关键词
枸橼酸氢钾钠颗粒
钠
钾
枸橼酸
离子色谱法
Potassium sodium hydrogen citrate granule
Sodium
Potassium
Citric acid
Ion chromatography
