HS-GC法测定利格列汀的7种残留溶剂  

Determination of 7 Residual Solvents in Ligretine by HS-GC

作　　者：章泽恒[1] 陆才洋[1] 龙慧玲[1] 王洪锋 朱婧 刘秀 龚翠云 ZHANG Ze-heng;LU Cai-yang;LONG Hui-ling;WANG Hong-feng;ZHU Jing;LIU Xiu;GONG Cui-yun(Hunan Center for Drug Evaluation and ADR Monitoring,Changsha 410013,China;Zhuzhou Qianjin Pharmaceutical Co.Ltd,Zhuzhou 412000,China)

机构地区：[1]湖南省药品审评认证与不良反应监测中心,湖南长沙410013 [2]株洲千金药业股份有限公司,湖南株洲412000

出　　处：《海峡药学》2023年第8期33-36,共4页Strait Pharmaceutical Journal

基　　金：湖南省自然科学基金科药联合基金项目(2022JJ80122)。

摘　　要：目的 建立顶空气相色谱法同时测定利格列汀中7种残留溶剂的分析方法。方法 采用顶空气相色谱(HS-GC)法,色谱柱为Agilent DB-624(30 m×0.53 mm, 3μm),程序升温,检测器为氢火焰离子化检测器(FID),氮气为载气。结果 在选定的色谱条件下,各溶剂峰均能完全分离,分别在相应浓度范围内与峰面积呈良好线性关系,各溶剂检测限均符合要求。结论 该方法操作简便、专属性强、灵敏、结果准确,适用于利格列汀的残留溶剂测定。OBJECTIVE To establish a capillary gas chromatography(GC)method with headspace sampling for the determination of 7 residual solvents in ligretine.METHODS HS-GC method was performed using an Agilent DB-624(30 m×0.53 mm,3μm)capillary column,with temperature programming and a flame ionization detector(FID)as the detector.Nitrogen was used as the carrier gas.RESULTS The peaks of these residual solvents were completely separated,and their calibration curves showed good linearity with their peak areas over the related concentrations ranges.The limit of detection for each solvent met the requirements.CONCLUSION The method is simple,specific,sensitive and accurate,which can be applied for control of solvent residues in ligretine.

关 键 词：DPP-4抑制剂 利格列汀 残留溶剂 顶空气相色谱法 

分 类 号：R927[医药卫生—药学]