Quality Evaluation of Naokangtai Capsules Based on QAMS,Chemometrics,and GRA
Objective:To establish a method for determining the content of 13 components in Naokangtai Capsules,including hy-droxy safflor yellow A,safflor yellow A,sodium danshensu,salvianolic acid B,dihydrotanshinone Ⅰ,tanshinone Ⅰ,tanshinone ⅡA,li-gustrazine H,ligustrazine Ⅰ,ligustrazine A,ligustilide,curdione,and curcumol,and to evaluate the overall quality of Naokangtai Capsules using chemometrics and grey relational analysis(GRA).Methods:The quantitative analysis of multiple components(QAMS)was applied,using acetonitrile-0.1%phosphoric acid as the mobile phase for gradient elution.The detection wavelengths were set at 403 nm(for hydroxy safflor yellow A and safflor yellow A),280 nm(for sodium danshensu,salvianolic acid B,dihydro-tanshinone Ⅰ,tanshinone Ⅰ,tanshinone ⅡA,ligustrazine H,ligustrazine Ⅰ,ligustrazine A,and ligustilide),and 214 nm(for curdione and curcumol).Chemometric analysis and GRA were applied to analyze the correlation and differences in the content of the multi-ple components.Results:The method validation results met the required criteria.The 13 components showed good linear relation-ships within their respective ranges(r>0.999 0),and the average recovery rates(n=9)ranged from 96.92%to 100.14%(RSD<2.0%).Chemometric analysis revealed that hydroxy safflor yellow A,salvianolic acid B,tanshinone ⅡA,ligustrazine A,and curdione were the key potential markers affecting the quality of Naokangtai Capsules.The relative correlation coefficients ranged from 0.350 4 to 0.638 7,and capsules with more recent production dates showed smaller quality differences.Conclusion:The QAMS method for simultaneously determining the content of 13 components in Naokangtai Capsules is simple and practical.Chemo-metrics and GRA can effectively be used to evaluate the overall quality of the product.