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Raman spectroscopy with the help of sophisticated data analysis techniques based on multivariate analysis have made it possible to study the full information of Raman spectra and to draw conclusions about the chemical structure and composition of very complex systems. As Raman spectroscopy has the advantage to provide rich information of the sample, so it was first included in Chinese Pharmacopoeia (2010) as “Annex XIX L Guidelines of Raman spectroscopy”. However the validation method for multicomponent quantitative analysis of Raman spectroscopy was not discussed in this pharmacopoeia. The purpose of this study was to develop innovatively the validation method for the Raman model in multicomponent quantitative analysis. Two kinds of samples with different matrix background were used to study the self-performance test of the instrument, linearity, limit of quantitation, accuracy and precision, respectively. As the sample was complex composition in our study, so there is no need to provide sample blank and rupture test for specificity study which was carried out in the traditional method of experiments. As the result showed, we propose a validation method for Raman spectroscopy in multicomponent analysis for the further study and improvement of standards of the method.
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