Chinese Journal of Pharmacovigilance ›› 2025, Vol. 22 ›› Issue (1): 76-83.
DOI: 10.19803/j.1672-8629.20240568

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Study on Catalpol Determination in Rehmanniae Radix

DAI Mengru1,2, LI Chun1, ZHANG Yongxin1, LU Yu1, CHENG Boyu1, FENG Weihong1,*   

  1. 1Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicines, Beijing 100700, China;
    2Yichun University, Jiangxi Province Primary Laboratory of Crop Growth and Development Regulation,Yichun Jiangxi 336000, China
  • Received:2024-08-12 Online:2025-01-15 Published:2025-01-22

Abstract: Objective To establish a method of UPLC for the determination of catalpol in Rehmanniae Radix so as to improve the quality standard of Rehmanniae Radix. Methods A Boltimate LP-C18 chromatographic column (4.6mm× 50 mm, 2.7μm) was used while pure water was used as the mobile phase and extraction solvent. The detection wavelength was set at 194 nm, the flow rate was 0.6 ml min-1, the column temperature was 35℃, and the sample volume was 1 μL. The contents of catalpol in 3 batches of fresh Rehmanniae Radix and 7 batches of raw Rehmanniae Radix were determined, and the result was compared with the one determined using the method specified in Chinese Pharmacopoeia. Results The RSDs of precision, repeatability, stability and spiked recovery tests of the new method were all below 0.5. Compared with the method specified in the current Chinese Pharmacopoeia, the sensitivity, reproducibility and accuracy of the new method were higher. The new method could complete the preparation of the test solution within 15 min, and accurately determine the content of catalpol in fresh/raw Rehmanniae radix within 10 min. Conclusion This method is simple, environmentally friendly, time-saving, and does not need any organic solvent. It can effectively prevent catalpol degradation in an acid environment, accurately determine catalpol contents, and provide a feasible method for quality control of Rehmanniae Radix. and its related preparations.

Key words: Rehmanniae Radix, Catalpol, Content Determination, Core-Shell Column, Ultra Performance Liquid Chromatography (UPLC), Chinese Pharmacopoeia of the People's Republic of China

CLC Number: