关键词: 盐酸二甲双胍, 格列美脲, 毛细管区带电泳, 含量测定

Abstract: To develop a capillary zone electrophoresis(CZE)method for the simultaneous quantitative analysis of metformin hydrochloride(MET)and glimepiride(GLM)in compound metformin tablets.CZE with UV detector at 229 nm was applied using a silica capillary column(50 μm×80 cm, effective length of 50 cm).The sample was employed with an electrokinetic injection of 5 kV for 12 s.The separation buffer was composed of 5 mmol/L sodium tetraborate buffer(pH 7.0).CE method was performed at room temperature and the running voltage was 17 kV.The results showd that the linear range of MET and GLM were 20~1 800 μg/mL(R=0.972 7)and 5~200 μg/mL(R = 0.990 6), respectively.The average recoveries of GLM and MTE at high, middle and low concentrations were 101.0%, 103.2%, 101.3% and 100.5%,100.7%, 99.8%, respectively.The contents of MET and GLM in three samples were 109.6%,- DOI:10.3969/j.issn.1000-1565.2018.01.008CZE法同时测定复方二甲双胍片中盐酸二甲双胍和格列美脲含量李海鹰,段雨萌,贾蓓,左月月,杨文智(河北大学 药学院,河北省药物质量分析控制重点实验室,河北 保定 071002)摘 要:采用毛细管区带电泳法(CZE)同时测定复方二甲双胍片中格列美脲(Glimepiride,GLM)和盐酸二甲双胍(Metformin hydrochloride,MET)含量.选用未涂层石英毛细管柱(50 μm×80 cm,有效长度50 cm),以5 mmol/L硼砂缓冲液(pH=7)为分离缓冲溶液,运行电压17 kV,电进样5 kV×12 s,紫外检测器(λ=229 nm).结果表明:MET和GLM质量浓度分别在20~1 800 μg/mL(R=0.972 7)和5~200 μg/mL(R=0.990 6)内与峰面积呈良好的线性关系,MET和GLM 2种药物的高、中、低3个质量浓度平均回收率分别为101.0%、103.2%、101.3%和100.5%、100.7%、99.8%.自制的3批复方降糖片中MET标示量质量分数分别为109.6%、108.2%、108.5%,GLM的标示量质量分数分别为100.9%、100.3%、104.5%.CZE法可用于复方二甲双胍片中MET和GLM的含量测定,方法简便,准确性好.关键词:盐酸二甲双胍;格列美脲;毛细管区带电泳;含量测定中图分类号:O657.7 文献标志码:A 文章编号:1000-1565(2018)01-0049-06Simultaneous determination of metformin hydrochloride andglimepiride in compound metformin tablets by CZE LI Haiying,DUAN Yumeng, JIA Bei, ZUO Yueyue, YANG Wenzhi(Key Laboratory of Pharmaceutical Quality Control of Hebei Province,College of Pharmacy,Hebei University, Baoding 071002, China)Abstract: To develop a capillary zone electrophoresis(CZE)method for the simultaneous quantitative analysis of metformin hydrochloride(MET)and glimepiride(GLM)in compound metformin tablets.CZE with UV detector at 229 nm was applied using a silica capillary column(50 μm×80 cm, effective length of 50 cm).The sample was employed with an electrokinetic injection of 5 kV for 12 s.The separation buffer was composed of 5 mmol/L sodium tetraborate buffer(pH 7.0).CE method was performed at room temperature and the running voltage was 17 kV.The results showd that the linear range of MET and GLM were 20~1 800 μg/mL(R=0.972 7)and 5~200 μg/mL(R = 0.990 6), respectively.The average recoveries of GLM and MTE at high, middle and low concentrations were 101.0%, 103.2%, 101.3% and 100.5%,100.7%, 99.8%, respectively.The contents of MET and GLM in three samples were 109.6%,- 收稿日期:2017-04-09 基金项目:河北省自然科学基金面上项目(H2018201045,H2017201052);河北省高等学校科学技术研究项目(DZ2016102);河北大学大学生创新创业计划训练项目(201710075014,201710075074) 第一作者:李海鹰(1973—),女,内蒙古集宁人,河北大学副教授,博士,主要从事药物分析及药物制剂方面的研究.E-mail: lihylihy@163.com第1期李海鹰等:CZE法同时测定复方二甲双胍片中盐酸二甲双胍和格列美脲含量 108.2%,108.5%, and 100.9%, 100.3%, 104.5%, respectively.The CZE method is rapid, simple, convenient and accurate.It can be used to detect the content of MET and GLM in compound metformin tablet.

Key words: metformin hydrochloride(MET), glimepiride(GLM), capillary zone electrophoresis(CZE), content determination