维格列汀原料药有关物质测定方法的研究  

Study on the determination of related substances in vildagliptin

作　　者：黄艳[1] 杨雪峰 陈雪云 符乃光[1] 陈年根[1] 钟霞[1] HUANG Yan;YANG Xuefeng;CHEN Xueyun;FU Naiguang;CHEN Niangen;ZHONG Xia(School of Pharmacy,Hainan Medical University,Haikou 571199,China;Haikou Nanlu Pharmaceutical Technology Co.,Ltd,Haikou 570311,China)

机构地区：[1]海南医学院药学院,海南海口571199 [2]海口南陆医药科技股份有限公司,海南海口570311

出　　处：《中国医药科学》2017年第15期42-45,共4页China Medicine And Pharmacy

基　　金：海南省产学研一体化专项项目(CXY20140011)

摘　　要：目的建立高效液相色谱法测定维格列汀原料药的有关物质。方法采用Waters XTerra MS C_(18)柱(4.6mm×50mm,3.5μm),以磷酸盐缓冲液-水-乙腈-甲醇(80:120:3:3)为流动相A,以磷酸盐缓冲液-乙腈-甲醇(8:9:3)为流动相B,梯度洗脱,检测波长为210nm;流速1.5m L/min。结果维格列汀与相邻杂质峰以及各杂质峰之间的分离度均大于1.3,检测限为1.2~1.6ng,定量限为2.4~3.3ng。结论该方法适用于维格列汀关物质的测定。Objective To establish an HPLC method to determine the related substance in Vildagliptin.MethodsThe column was Waters XTerra MS C18(4.6mm×50mm,3.5μm),the mobile phase A was treated with phosphatebuffer-water-acetonitrile-methanol(80:120:3:3),the mobile phase B was treated with phosphate buffer-wateracetonitrile-methanol(8:9:3),which was used as gradient elution.The detection wavelength was210nm,the flow ratewas1.5mL/min.Results The resolution of vildagliptin and its related substance was above1.3,detection limit was1.2～1.6ng,quantification limit was2.4～3.3ng.Conclusion The method was suitable for the determination ofrelated substance in vildagliptin.

关 键 词：高效液相色谱法 维格列汀 有关物质 测定 

分 类 号：R927[医药卫生—药学]