复方甘草酸苷中有关物质的测定  

Determination of the Related Substances of Compound Glycyrrhizin Tablet by RP-HPLC

作　　者：田莉[1] 高晓黎[2,3] 田春海 云奇 

机构地区：[1]新疆医科大学中医学院,新疆乌鲁木齐830011 [2]新疆医科大学药学院,新疆乌鲁木齐830011 [3]新疆特丰药业股份有限公司,新疆乌鲁木齐830011 [4]新疆维吾尔自治区食品药品监督管理局,新疆乌鲁木齐830002

出　　处：《时珍国医国药》2009年第4期925-927,共3页Lishizhen Medicine and Materia Medica Research

基　　金：新疆维吾尔自治区科技攻关(含重大专项)和重点项目计划(No.200733146);乌鲁木齐市科学技术计划项目(No.Z041401)

摘　　要：目的建立同时测定复方甘草酸苷片中3个主成分有关物质的反相高效液相色谱法(二极管阵列检测器),以控制其质量。方法采用C18色谱柱,以0.025 mol.L-1醋酸钠溶液(pH 3.5)-乙腈(59∶41)洗脱,检测波长251,360 nm。结果样品中各主成分与有关物质的分离度及检出灵敏度可满足测定要求,甘草酸单铵盐,甘氨酸,DL-蛋氨酸最低检出限分别为2.02,0.28,0.96 ng。结论该法灵敏、准确、简便、专属性强,可作为该制剂质量控制的有效手段。Objective To develop a reversed - HPLC method （PDA） for simultaneous determination of related substances of three major components in compound glyeyrrhizin tablet. Methods A C18 column was used with the mobile phase of 0.025 mol.m 1^-1 NaAC solution （ pH 3.5 ） - aeetonitrile （59：41 ） and the detection wavelength was at 251 nm and 360 nm. Results Resolution and detectable sensitivity of each constituent in samples satisfied the detection demand of related substance. The LOD of glycyrrhizin , glyeine, DL- methionine were 2.02 ng,0.28 ng and 0.96 ng, respectively. Conclusion The method is sensitive, accurate, simple and specific. It can be used as a reliable method for the quality control of compound glycyrrhizin tablet.

关 键 词：复方甘草酸苷片 甘草酸单铵盐 甘氨酸 DL-蛋氨酸 有关物质 反相高效液相色谱法 

分 类 号：R284.2[医药卫生—中药学]