GLP体系下高效液相色谱仪的3Q验证  

3Q Validation of High Performance Liquid Chromatograph in GLP System

作　　者：刘静[1] 张谦[1] 王芳[1] 肖云峰[1] 常福厚[1] Liu Jing;Zhang Qian;Wang Fang;Xiao Yunfeng;Chang Fuhou(Department of Pharmacy,Affiliated Hospital of Inner Mongolia Medical University,Hohhot,Inner Mongolia 010110,China)

机构地区：[1]内蒙古医科大学新药安全评价研究中心

出　　处：《北方药学》2019年第8期1-3,共3页Journal of North Pharmacy

摘　　要：目的:以日立Chromaster高效液相色谱仪为例,探究良好实验室规范(GLP)体系下高效液相色谱仪3Q验证过程。方法:本实验通过对高效液相色谱仪的泵、柱温箱、检测器进行性能验证,从而证明该仪器符合使用要求,保证分析数据准确可靠。结果:液相色谱仪的泵、柱温箱、检测器以及整机性能验证符合使用要求,可进行分析实验,分析数据准确可靠。结论:通过GLP体系下的3Q验证,日立Chromaster高效液相色谱仪各方面性能优良,可以用于供试品及试剂管理部的含量测定。Objective:To explore the procedures of 3Q validation under the good laboratory practice(GLP)system based on the Hitachi Chromaster high performance liquid chromatograph(HPLC). Methods:In this experiment,the performance of the pump,column oven and detector of the high performance liquid chromatograph is verified,which proves that the instrument meets the requirements of use and ensures that the analytical data is accurate and reliable. Results:Based on the above research,the performance of the pump,column oven,detector and machine performance of the liquid chromatograph meets the requirements for use,and further analysis experiments can be carried out,and the analysis data is accurate and reliable. Conclusion:Through the 3Q verification under the GLP system,Hitachi Chromaster High Performance Liquid Chromatograph has excellent performance in all aspects and can be used for the content determination of the test and reagent management department.

关 键 词：良好实验室规范 高效液相色谱仪 3Q验证 

分 类 号：R197.39[医药卫生—卫生事业管理]