Objective: To establish a method for characteristic chromatogram of Perillae Folium formula granules and to determine the content of the main ingredient scutellarin for quality evaluation. Methods: The test solution preparation method was determined by systematically investigating various extraction parameters, evaluated by the extraction rate of characteristic peaks and quantitative component. The chromatographic separation was performed on a Waters ACQUITY UPLC HSS T3 column (100 mm×2.1 mm, 1.8 μm) using a mixture of acetonitrile and 0.2% phosphoric acid in water as the mobile phase in gradient elution mode. The flow rate was 0.4 mL·min-1, the column temperature was set as 25 ℃ and the detection wavelength was set as 334 nm. Results: The established method was verified by systematic methodology including precision, repeatability, stability and recovery, and the results accorded with the requirements. The investigation results of different chromatographic columns, instruments, column temperatures and mobile phases showed that the method was well tolerated. This method was used to analyze and determine 12 bathes of Perillae Folium formula granules from 3 different sources. A total of 5 common peaks were demarcated from the characteristic chromatograms of Perillae Folium formula granules, and 4 chemical components were identified as luteolin-7-O-diglucuronide (peak 2), apigenin-7-O-diglucuronide (peak 3), scutellarin (peak 4) and rosmarinic acid (peak 5). The similarities of the chromatograms from 12 batches of samples were higher than 0.9. Principal components analysis (PCA) results showed peak 2, peak 3 and peak 4 were the main factors affecting the quality evaluation of Perillae Folium formula granules. The contents of scutellarin were in a range of 0.16%-1.86%. Conclusion: The method is quick, accurate and reproducible, and suitable for evaluating the quality of Perillae Folium formula granules.
HAN Yuan-yuan, KIM Moo-seob, GU Li-hua, WANG Zheng-tao
. Study on the quality standard of Perillae Folium formula granules based on UPLC*[J]. Chinese Journal of Pharmaceutical Analysis, 2022
, 42(12)
: 2210
-2217
.
DOI: 10.16155/j.0254-1793.2022.12.19
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