离子色谱法测定葡萄糖酸钙注射液中葡萄糖酸根的含量  

Quantitative determination of gluconate in calcium gluconate injection by ion chromatography

作　　者：李婕[1] 韩春霞 黄海伟[1] 张岩琛 何兰[1] LI Jie;HAN Chun-xia;HUANG Hai-wei;ZHANG Yan-chen;HE Lan(National Institutes for Food and Drug Control,Beijing 102629,China;Thermo Fisher Scientific,Shanghai 201206,China;Changzhou Institute for Food and Drug Control,Changzhou 213002,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]赛默飞世尔科技中国有限公司,上海201206 [3]常州市食品药品监督检验中心,常州213002

出　　处：《中国新药杂志》2020年第23期2744-2747,共4页Chinese Journal of New Drugs

摘　　要：目的:建立离子色谱法测定葡萄糖酸根的含量。方法:采用抑制型离子色谱法,Dionex IonPac AS18(250 mm×4 mm)阴离子交换柱、Dionex IonPac AG18(50 mm×4 mm)保护柱和Dionex On GuardTMⅡNa Cartridges(1 mL)样品预处理小柱,以KOH为淋洗液,进行梯度洗脱:0~20 min,1×10^-3mol·L^-1;20~25 min,40×10^-3mol·L^-1;25~35 min,1×10^-3mol·L^-1,采用电导检测器。结果:葡萄糖酸根与乳酸根分离良好,在1~25μg·mL^-1范围内呈良好的线性关系(r=0.999);定量限为1μg·mL^-1;回收率为101.5%(n=9,RSD=2.5%)。结论:该方法灵敏、准确、简便,专属性好,可用于测定葡萄糖酸钙注射液中葡萄糖酸根的含量。Objective: To establish a quantitative determination method for gluconate by ion chromatography.Methods: A suppressed ion chromatography was applied using Dionex IonPac AS18 column(4 mm × 250 mm)with a guard column adopting a gradient elution of KOH,0 ~ 20 min,1 × 10^-3 mol·L^-1;20 ~ 25 min,40 × 10^-3 mol·L^-1;25 ~35 min,1 ×10^-3 mol·L^-1.A conductivity detector was used.Samples were pretreated by an off-line sample preparation technique with DionexTMOn GuardTMII Na Cartridges(1 m L).Results: A satisfactory separation of gluconate and lactate was obtained.The standard curve was rectilinear in the range of 1 ~ 25 μg·mL^-1(r =0.999).The limit of quantification was 1 μg·mL^-1.The average recovery was 101.5%(n = 9;RSD = 2.5%).Conclusion: The developed method is accurate,simple,selective and robust and could be successfully applied for the assay of gluconate in calcium gluconate injection.

关 键 词：离子色谱 葡萄糖酸根 含量 保护柱 

分 类 号：R917[医药卫生—药物分析学]