HPLC Fingerprint and Multi-component Content Determination of Libi Tablets
Objective To evaluate the quality of Libi tablets by establishing a multi-component con-tent determination method combined with chemometrics analysis.Methods HPLC was adopted on a Waters SunFire C18(4.6 mm×250 mm,5 μm)column.The mobile phase was acetonitrile-0.55%phos-phoric acid at a flow rate of 1.0 ml·min-1 with gradient elution.The detection wavelength was set at 323 nm,280 nm amd 248 nm respectively.The column temperature was 35℃and the injection volume was 10 μl.The quality of 15 batches of Libi tablets was evaluated via the similarity evaluation system for chromatographic fingerprints of TCM combined with cluster analysis and principal component analysis.Results The results showed that 19 common peaks were identified,7 of which were peaks of chromatogra-phy.The average recoveries of chicoric acid,chlorogenic acid,caffeic acid,baical,magnolin,imperatorin,and isoimperatorin in Libi tablets were 100.30%,99.87%,99.25%,99.45%,99.08%,98.75%,98.58%,respectively,and the RSDs were all below 1.5%(n=6).The contents of the above 7 compo-nents in 15 batches of samples were 15.05―17.93,10.17―12.51,7.03―9.30,4.42―6.50,1.08―2.76,1.01―1.76,1.00―1.90 mg·g-1,respectively.Chemometric analysis showed that there was some difference between the samples of different batches.Significant characteristic peaks for discrimination between different samples were chicoric acid,chlorogenic acid and magnolin.The results of hierarchical cluster analysis showed that the samples from the three enterprises were grouped into one category respec-tively,namely S1-S4(Shaanxi Kanghui),S5-S10(Tonghua Mintai),and S11-S15(Changchun Yinnuoke).The results of orthogonal partial least square discriminant analysis(OPLS-DA)showed that these four chemical components[peak 10(VIP value 2.216),peak 6(VIP value 1.934)unknown,peak 4(VIP value 1.438),peak 13(VIP value 1.013)]made much difference to the categorization of Libi tablets,which were potential marker components that caused quality differences of the preparation and could be considered indica-tor components to monitor the quality of Libi tablets.Conclusion The established quality evaluation method is simple,specific and accurate,which can objectively evaluate the quality of Libi tablets.
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