Quality Control

Quality evaluation of Simiao pills based on fingerprint combined with TRSDMC*

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  • 1. College of Pharmacy, Chengdu University of TCM, Chengdu 611137, China;
    2. Chongqing Institute for Food and Drug Control, Chongqing 401121, China;
    3. Jiangxi Provincial Research Institute for Drug Control, Nanchang 330029, China;
    4. College of Pharmacy, Southwest University, Chongqing 400715, China;
    5. National Institute for Food and Drug Control, Beijing 100050, China

Received date: 2021-06-25

  Online published: 2024-06-24

Abstract

Objective: To establish the HPLC fingerprint of Simiao pills, and to evaluate the quality of Simiao pills by using chemometrics and two reference substances for determination of multiple components. Methods: The fingerprint of Simiao pills was established by HPLC, with acetonitrile as mobile phase A and 0.1% phosphoric acid aqueous solution as mobile phase B in gradient elution mode. The flow rate was 1 mL·min-1, the detection wavelength were 327 nm(0-17 min), 284 nm(18-30 min) and 340 nm(31-92 min), and the column temperature was 30 ℃. Chemometrics analysis was used for quality evaluation. The actual retention time of eight characteristic peaks in Simiao pills was determined on 12 different types of C18 chromatographic columns. Chlorogenic acid (peak 4) and berberine(peak 14) were selected as the reference substances for the determination. Linear calibration using two reference substances (LCTRS) method was used to accurately identify the eight characteristic chromatographic peaks, and the method could be verified on an unknown chromatographic column. Taking berberine as reference, the contents of chlorogenic acid and phellodendrine were determined, and the results were compared with the external standard method (ESM). Results: Sixteen chromatographic peaks were selected as common peaks in the fingerprints of 13 batches of Simiao pills. Preliminary evaluation of the quality was made by chemometrics evaluation, and the eight characteristic peaks attributed by reference methodwere further selected for LCTRS. The results show that the LCTRS has a higher accuracy (100%) in predicting retention time.And the LCTRS was superior to the relative retention time(RRT) method. The relative correction factors of chlorogenicacid and phellodendrine to berberine were 0.778 2 and 0.241 5, respectively. The results showed that there was no significant difference between the relative correction factor method(RCFM) and the ESM. Conclusion: The method of LCTRS improves the accuracy of the retention time prediction of chromatographic peaks, and can be better used in the determination of the multi-component content of Simiao pills.

Cite this article

GOU Hua-mei, ZHANG Yi, WU Yan-hong, YANG Rong-ping, XU Yan, SUN Lei . Quality evaluation of Simiao pills based on fingerprint combined with TRSDMC*[J]. Chinese Journal of Pharmaceutical Analysis, 2022 , 42(5) : 866 -874 . DOI: 10.16155/j.0254-1793.2022.05.16

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