Quality Evaluation of Mailuoshutong Pills Based On Multi-Wavelength Switching HPLC Fingerprint Combined With Chemometrics and Multi-Indicator Content Determination
OBJECTIVE To establish a quality evaluation method for Mailuoshutong Pills by combining fingerprints and multi indicator quantification combined with chemometrics.METHODS Agilent ZORBAX SB-Aq C18 chromatography column(4.6 mm × 250 mm,5 µm)was used,and the column temperature was maintained at 30 ℃.The mobile phase was acetonitrile-0.1%phosphoric acid aqueous solution.Gradient elution was carried out at a flow rate of 1.0 mL·min-1,and the detection wavelengths were 216,230,280,248,327,280 and 254 nm.The fingerprints of Mailuoshutong Pills(MLSTP)were established,the common peaks were determined combined with chemometric analysis,and the contents of 11 indicator components were determined.RESULTS A total of 30 common peaks were labeled in the fingerprints,and 12 components were identified through comparison with reference materials.The similarity of fingerprints of 16 batches of MLSTP were more than 0.990.Through cluster analysis,principal component analysis,and partial least squares discriminant analysis,it was found that gallic acid,neochlorogenic acid,cryptochlorogenic acid,chlorogenic acid,paeoniflorin,berberine hydrochloride,calycosin-7-glucoside,isochlorogenic acid A,isochlorogenic acid C,hapargoside,and berber-ine hydrochloride were the main factors affecting the quality of MLSTP,and the variation ranges of the content determination of the 11 components mentioned above were 0.62-0.84,1.45-2.50,1.30-2.78,3.35-5.28,2.44-4.02,0.54-0.88,0.16-0.23,0.61-0.76,1.39-1.76,0.41-0.54 and 2.28-3.34 mg·g-1,respectively.CONCLUSION The established multi-wave-length switching fingerprint spectrum combined with chemometric analysis and multi index content determination method is stable and reliable,which can provide scientific basis for the quality control and comprehensive evaluation of MLSTP.