Quality Evaluation of Baipuhuang Capsules by UPLC Fingerprint Combined with Chemical Pattern Recognition
Objective To establish an ultra-high performance liquid chromatography(UPLC)fingerprint and chemical pattern recognition method for evaluating the quality of Baipuhuang Capsules.Methods The chromatography column was Waters Acquity BEH C18 column(150 mm×2.1 mm,1.7 µm),the mobile phase was acetonitrile-0.02 mol/L potassium dihydrogen phosphate solution(gradient elution),the flow rate was 0.3 mL/min,the column temperature was 35℃,the switching wavelengths were 210 nm and 323 nm,and the injection volume was 2 µL.The fingerprints of ten batches of samples from two manufacturers were established,and the similarity evaluation,clustering analysis(CA),and orthogonal partial least squares-discriminant analysis(OPLS-DA)were conducted to screen for differential biomarkers in different batches of samples.Results The methodological examination results showed that the RSDs of the precision,repeatability,and stability test results of the seven components were all lower than 2.0%.Nineteen common peaks were calibrated in ten batches of samples.By comparing with the reference substance,seven components were identified,namely phellodendrine hydrochloride(peak 4),chlorogenic acid(peak 6),caffeic acid(peak 10),chicoric acid(peak 11),baicalin(peak 13),berberine hydrochloride(peak 17),and pulchinenoside B4(peak 19).The similarity of the fingerprints of ten batches of samples was 0.978 or above.Ten batches of samples were classified into two categories according to the manufacturers.Under the OPLS-DA model,four differential biomarkers were screened based on the variable importance in projection(VIP)value greater than 1,namely pulchinenoside B4(peak 19),peak 5,chicoric acid(peak 11),and chlorogenic acid(peak 6).Conclusion The method is simple and accurate,which can objectively evaluate the quality of Baipuhuang Capsules.