摘要
目的以葡萄糖的近红外定量分析为基础,探索和建立近红外光谱法用于定量分析方法学验证的评价指标。方法采用3组不同基质的样品各100份,分别从仪器性能、线性相关系数、定量限、准确度、精密度和专属性等进行方法学分析和评价。结果对各项方法学指标提出了相关验证方法和参考评价指标。结论提出了采用近红外定量分析的方法学验证和评价方法,为近红外方法学验证评价指标的完善和分析标准的制定提供了参考依据。
OBJECTIVE To develop an innovative validation and evaluation method of quantitative analysis for NIR spectroscopy(NIRS)at base of quantitative analysis for glucose by NIRS.MEHTODS With three kinds of 100 samples on different matrix background,the validation standards were analyzed and evaluated for the NIRS method,of which performance of the NIRS instrument,linearity correlation coefficient(r 2),limit of quantitation,accuracy and precision,were analyzed and evaluated for the NIRS method.RESULTS For each validation standard,a validation method was firstly proposed for the quantitative analysis of NIR spectroscopy.CONCLUSION The established NIRS validation method for the quantitative analysis is robust,providing the basis and formulation for the improvement of the standard.
作者
李春燕
薛金涛
叶利明
LI Chunyan;XUE Jintao;YE Liming(Sanquan College of Xinxiang Medical University,Xinxiang,Henan,453002 P.R.China;School of Pharmacy,Xinxiang Medical University,Xinxiang,Henan,453003 P.R.China;West China School of Pharmacy,Sichuan University,Chengdu,Sichuan,610041 P.R.China)
出处
《华西药学杂志》
CAS
CSCD
2022年第4期395-397,共3页
West China Journal of Pharmaceutical Sciences
基金
河南省重点研发与推广专项(科技攻关)(222102310566)。
关键词
方法学验证与评价
近红外光谱法
定量分析
葡萄糖
线性
定量限
准确度
精密度
专属性
Methodology validation and evaluation
Near-infrared spectroscopy
Quantitative analysis
Glucose
Linearity
Limit of quantitation
Accuracy
Precision
Specificity
