液相色谱仪的FDA仪器认证方法探讨

Discussion of FDA Liquid Chromatography Instruments Certification Methods

介绍液相色谱仪符合FDA仪器性能认证的方法。以紫外检测器液相色谱仪为例,主要对波长示值误差和重复性、检测器线性、自动进样器的准确性和线性等检定规程中没有或者确认方法不同的项目进行确认,确认仪器影响分析结果的性能指标是否控制在合理的范围内,以保证液相色谱仪正常分析药品的质量。

Certification methods of liquid chromatography conforming with FDA instrument performance wereintrouduced. UV detector liquid chromatography was taken as an example,error of wavelength indication and repeatability,linearity of detector,accuracy of autosampler which were not found in verification regulation or different items inconfirmation methods were confirmed. It was confirmed that if the performance items influencing the results could becontrolled in a reasonable range,in order to ensure the normal analysis of the quality of medicine by liquid chromatography.