HPLC法测定复方锌铁钙口服溶液中总葡萄糖酸根含量  

Determination of Total Gluconate Acid Radical in Compound Zinc,Iron and Calcium Oral Solution by HPLC

作　　者：李琦 刘雁鸣 李钰鑫 李晓燕 LI Qi;LIU Yanming;LI Yuxin;LI Xiaoyan(Hunan Institute for Drug Control,Changsha 410001,China;Key Laboratory of Pharmaceutical Excipients Engineering Technology Research,National Medical Products Administration,Changsha 410001,China;Hunan Engineering Technology Research Center for Drug Quality Evaluation,Changsha 410001,China;Hunan Drug Inspection Center Changsha 410001,China)

机构地区：[1]湖南省药品检验检测研究院,湖南长沙410001 [2]国家药品监督管理局药用辅料工程技术研究重点实验室,湖南长沙410001 [3]湖南省药品质量评价工程技术研究中心,湖南长沙410001 [4]湖南省药品审核查验中心,湖南长沙410001

出　　处：《工业微生物》2025年第1期253-256,共4页Industrial Microbiology

基　　金：湖南省自然科学基金科药联合基金(编号:2022JJ80009)。

摘　　要：文章建立HPLC法,以测定复方锌铁钙口服溶液中总葡萄糖酸根的含量。色谱柱为Ultimate XB NH_(2)(250 mm×4.6 mm,5μm),流动相为0.02 mol/L磷酸二氢钾溶液-乙腈(40∶60),检测波长为200 nm,流速为1.0 m L/min,进样量为20μL,柱温为30℃。运用该方法,乳酸与葡萄糖酸能有效分离,且阴性样品不干扰葡萄糖酸根的测定;葡萄糖酸盐在130.36~651.8μg/mL质量浓度范围内线性关系良好(r=0.999),平均回收率为101.34%(SRSD为0.96%)。该方法专属性强、操作简便、灵敏度高、重复性好,能准确测定复方锌铁钙口服溶液中总葡萄糖酸根的含量。The paper established an HPLC method for the determination of total gluconate acid radical in compound zinc,iron and calcium oral solution.The chromatographic column was Ultimate XB NH_(2)(250 mm×4.6 mm,5μm).The mobile phase was 0.02 mol/L potassium dihydrogen phosphate solution-acetonitrile(40∶60).The detection wavelength was 200 nm,the flow rate was 1.0 mL/min,the injection volume was 20μL,and the column temperature was 30℃.With this method,the lactic acid and gluconic acid could be effectively separated,and negative samples did not interfere with the determination of gluconate acid radical.Gluconate had a good linear relationship in the the mass concentration of 130.36—651.8μg/mL(r=0.999).The average recovery rate was 101.34%(S_(RS)D is 0.96%).This method had strong specificity,simple operation,high sensitivity and good repeatability,and can accurately determine the total gluconate acid radical in compound zinc,iron and calcium oral solution.

关 键 词：HPLC 复方锌铁钙口服溶液 葡萄糖酸根 

分 类 号：O657.72[理学—分析化学] TQ460.72[理学—化学]