中国药物评价2025，Vol.42Issue(1)：35-41,7.
HPLC-CAD法测定口服五维赖氨酸葡萄糖中葡萄糖含量
Determination of Glucose in Oral Five-Vitamin and Lysine Glucose Preparations by HPLC-CAD
摘要
Abstract
Objective:To establish a high-performance liquid chromatography-charged aerosol detector(HPLC-CAD)method for determining the glucose content in oral five-vitamin and lysine glucose preparations,and to compare the results obtained by this method with those of the iodometric method recorded in the current quality standards.Methods:HPLC-CAD is used;the chromatographic column is Waters XBridge BEH Amide(4.6 mm ×250 mm,5 μm).The mobile phase is 0.2％triethylamine aqueous solution and acetonitrile(25∶75);the flow rate is 1.0 mL·min-1.Clumn temperature is set at 30 ℃;the injection volume is 20 μL.Results:In the system suitability solution,baseline separation was achieved between glucose and sucrose,fructose,and lactose.The linear relationship of glucose is good within the range of 0.490 8 to 0.981 6 mg·mL-1(r=0.999 6).The quantification limit of the method is 0.2 μg,and the recovery rate is 100.82％to 102.58％(RSD=0.8％,n=6).The glucose content in 96 batches of samples from 4 production enter-prises across the country was determined using HPLC-CAD and iodometry,and the results were analyzed and compared.Due to the inter-ference of excipients in the 4 enterprises on the iodometry method,the true content of glucose could not be reflected.The HPLC-CAD method resulted in a lower glucose content than the iodometry method,indicating a more accurate result.Conclusion:This method is simple to operate,exhibits good specificity and high sensitivity,and can accurately determine the glucose content in oral five-vitamin and lysine glucose preparations.关键词
葡萄糖/含量测定/高效液相色谱/电喷雾检测器/口服五维赖氨酸葡萄糖Key words
Glucose/Assay/High performance liquid chromatography/Charged aerosol detector(CAD)/Oral five-vitamin and lysine glucose preparations分类
药学引用本文复制引用
刘庄蔚,朱健萍,蒋洁,何虹,谭菊英..HPLC-CAD法测定口服五维赖氨酸葡萄糖中葡萄糖含量[J].中国药物评价,2025,42(1):35-41,7.基金项目
2022年国家药品抽检计划项目(国药监药管[2022]1号,序号25) （国药监药管[2022]1号,序号25）
广西壮族自治区药品监督管理局科研计划项目(桂药监科[2022]-040号(直属)) （桂药监科[2022]-040号(直属）
医药用高端蔗糖产品生产应用关键技术开发与产业化示范(桂科AA22117005) （桂科AA22117005）
