Quality Evaluation of Guxian Tablets Based on Multi-Component Quantitative Analysis,Chemometrics,and Grey Relational Analysis
Objective To establish a quality evaluation method for Guxian Tablets.Methods High-performance liquid chromatography(HPLC)was used for the content determination of catalpol,rehmannioside D,rehmannioside A,leonuride,specnuezhenide,oleuropein,nuezhenoside G13,curculigoside B,curculigoside,neoeriocitrin,naringin,fangchinoline and tetrandrine in Guxian Tablets.The chromatography column was Nucleodur C18 column(250 mm × 4.6 mm,5 μm),the mobile phase was acetonitrile-0.1%phosphoric acid aqueous solution(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was set at 203 nm for catalpol,rehmannioside D,rehmannioside A and leonuride,224 nm for specnuezhenide,oleuropein and nuezhenoside G13,and 280 nm for curculigoside B,curculigoside,neoeriocitrin,naringin,fangchinoline and tetrandrine,the column temperature was 30 ℃ and the injection volume was 10 μL.The chemometrics and grey relational analysis(GRA)method was used to analyze the difference in the results of multi-index component content.Results The 13 components had good linear relationships within their respective ranges(r>0.999,n=6).The RSDs of precision,stability,and repeatability test results were all lower than 2.0%.The recovery rate of 13 components was in the range of 96.88%-100.14%,with RSD<2.0%(n=9).Cluster analysis(CA)showed that 18 batches of samples were clustered into three categories,while samples from the same manufacturer were clustered into one category.The results of principal component analysis(PCA)showed that the cumulative variance contribution rate of the three principal components with eigenvalues>1 was 89.367%.The results of orthogonal partial least squares-discriminant analysis(OPLS-DA)showed that catalpol,specnuezhenide,tetrandrine,naringin,rehmannioside D and neoeriocitrin were the main potential biomarkers affecting the quality of Guxian Tablets.GRA results showed that the relative correlation of the 18 batches of samples ranged from 0.337 9 to 0.623 6,and the difference in the quality of samples from the same manufacturer was little.Conclusion The established method has accurate results and good reproducibility,which can be used for the quality evaluation of Guxian Tablets.