Study of the chromatogram fingerprints of water-soluble components in Wuling Capsules based on Plackett Burman-central composite design
Objective To establish the chromatogram fingerprints of water-soluble components in Wuling Capsules based on the Plackett Burman-central composite design(PB-CCD).Methods The factors influencing the chromatogram fingerprint analysis were optimized firstly by utilizing PB experimental design.The sum of chromatographic peak resolutions(∑Rs),normalized resolution factors(r*),information contents(φ),and hierarchical chromatographic response function(HCRF)were set as response factors.Correspondingly,the detection wavelength,column temperature,duration time,sample inject volume,flow rate,and initial acetonitrile ratio etc.were set as observation factors.Subsequent optimization was conducted by using the CCD design to determine the optimal process for establishing the water-soluble component chromatogram fingerprints.Then,the similarity of the fingerprints of 10 batches Wuling Capsules was calculated by using the established methodology,and the quality of each batch was evaluated.Results Following the optimized parameters,the chromatogram fingerprints of water-soluble components in Wuling Capsules was established,and 15 common peaks were selected.The methodological examination indicates good specificity,repeatability,stability,and precision results.Furthermore,the similarity of the 10 batches of Wuling Capsule samples was calculated greater than 0.95.Conclusion The methodology for the Wuling Capsules water-soluble component chromatogram fingerprints was established by using the PB-CCD design,which exhibited a proper model fitting capabilities,and could be used for the quality control of this formulation in the future.
万方数据
维普
