CAJ | 학술논문

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。
개소액상색보의부합FDA의기성능인증적방법。이자외검측기액상색보의위례，주요대파장시치오차화중복성、검측기선성、자동진양기적준학성화선성등검정규정중몰유혹자학인방법불동적항목진행학인，학인의기영향분석결과적성능지표시부공제재합리적범위내，이보증액상색보의정상분석약품적질량。
Certification methods of liquid chromatography conforming with FDA instrument performance were introuduced. 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 in confirmation methods were confirmed. It was confirmed that if the performance items influencing the results could be controlled in a reasonable range,in order to ensure the normal analysis of the quality of medicine by liquid chromatography.