岛津20A高效液相色谱仪设备验证及研究

论文总字数：16348字

摘 要

随着药物研发及分析手段与日俱进，国家对药品生产销售的准入及管理越来越严格。其中一方面就体现在对生产企业及相关企业的药品质量控制部门要求的提高，对药品含量准确性、可靠性及标准化要求越来越高。高效液相色谱法作为药企实验室最常用的检验手段，高效液相色谱仪成为每个药企必备的检验仪器。而对高效液相色谱仪进行确认，包括安装确认（IQ）、运行确认（OQ）、性能确认（PQ），是该仪器用于日常检验、分析的前提。仪器验证保证仪器的精确性，为分析结果的真实性提供了依据。

关键字：HPLC；验证；确认

Verification and Research on Shimadzu 20A High Performance Liquid Chromatograph

Abstract

With the development of drug research and analysis, production and sales management of drug was more stringent by the state. One aspect of it is reflected in the improvement of the quality of pharmaceutical manufacturers and related companies control requirements, the accuracy of the content of the drug, standardization and reliability have become increasingly demanding. High-performance liquid chromatography as the most commonly used laboratory test methods. High-performance liquid chromatography as a necessary test equipment for each pharmaceutical companies. The confirmation of the high-performance liquid chromatograph is the prerequisite for the daily inspection and analysis of the instrument, including installation qualification (IQ), operation qualification (OQ) and performance qualification (PQ). Instrument verification ensures the accuracy of the instrument, and provides a basis for analyzing the authenticity of the results.

Keywords：HPLC；Verification；Affirmance

目录

摘 要················································································Ⅰ

Abstract················································································Ⅱ

第一章 引 言·········································································1

第二章 岛津20A高效液相色谱仪的验证····················································2

2.1 验证前确认工作·································································2

2.2 安装确认·······································································2

2.2.1 仪器安装确认·······························································2

2.2.2 HPLC系统检漏·······························································3

2.3 运行确认·······································································3

2.3.1 泵流量确认·································································3

2.3.2 梯度检查···································································5

2.3.3 柱温箱温度确认·····························································7

2.3.4 基线与噪音确认·····························································7

2.3.5 进样器确认·································································8

2.3.6 检测器波长准确度确认·······················································9

2.4 性能确认······································································11

2.4.1 进样残留测试······························································11

2.4.2 线性测试··································································11

2.4.3 重复性测试································································13

第三章 结束语·········································································15

致 谢（Reference）···································································16

参考文献··············································································17

第一章 引言

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