Fingerprint Study and Primary Quality Evaluation of Niuhuang Qingwei Pills Based on UPLC and Reference Drug / 中国药学杂志

ABSTRACT

OBJECTIVE： To apply reference drug in the fingerprint study of Niuhuang qingwei pills, and perform primary evaluation of the quality grade of the samples. METHODS： Ultra performance liquid chromatography (UPLC) separation was performed on an AQUITY UPLC BEH C18 column with gradient elution using acetonitrile (containing 0.5% formic acid)-0.5% formic acid at a flow rate of 0.2 mL•min-1. The injection volume was 2 μL and the column temperature was maintained at 40 ℃. The detection wavelength was set at 254 nm. By comparing with reference substances and the reference herbal materials, characteristic peaks and their ascriptions were investigated. Using Niuhuang qingwei pills reference drug as the accompanying physical control, the similarities of the fingerprints of 49 batches of samples from 18 manufacturers were calculated, and the quality grades were evaluated. RESULTS： The similarities of all samples fell within the range of 0.76-0.98. The similarities of 49 samples were above 0.75 and met the second-grade limit. The similarity of 24 samples were above 0.90 and met the first-grade limit. CONCLUSION： The method is simple, accurate and rapid. It can be used for the quality control and grade evaluation of Niuhuang qingwei pills, which provides reference for the quality grade research of Chinese patent medicines.