Standard Deliberation

Establishment of HPLC fingerprints and determination of six components for Zilian Shengji gel*

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  • Gansu Provincial Hospital of Traditional Chinese Medicine, Lanzhou 730050, China

Revised date: 2024-06-12

  Online published: 2024-10-17

Abstract

Objective: To establish the HPLC fingerprints for Zilian Shengji gel and to determine the contents of gallic acid, tableberberine, coptisine, palmatine, berberine and shikonin. Methods: The establishment of fingerprints was performed on a 25 ℃ thermostatic Agilent C18-WR(250 mm×4.6 mm, 5 μm)column with the mobile phase comprising of acetonitrile-0.15% phosphoric acid water at the flowing rate of 0.8mL·min-1 in a gradient elution manner,and the detection wavelength were set at 270 nm, 345 nm and 516 nm. Cluster analysis,principal component analysis(PCA) and orthogonal partial least squares discriminant analysis(OPLS-DA) were adopted in chemical pattern recognition. The six components identified were quantitatively determined. Results: The HPLC fingerprint of Zilian Shengji gel was constructed with twenty-six common chromatographic peaks, eleven batches of samples with the similarities of 0.828-0.997, six chromatographic peaks of gallic acid, tableberberine, coptisine, palmatine, berberine and shikonin were identified by reference substance comparison. Six constituents showed good linear relationships within their own ranges (r≥0.999 5) whose average recoveries were 98.7%-99.3%, with the RSDs of 1.3%-1.8%. The content ranges of the above mentioned six components in eleven batches of samples were 827.74-1 513.50 μg·g-1,137.52-296.05 μg·g-1, 381.83-884.73 μg·g-1, 2 023.81-4 051.66 μg·g-1, 524.15-986.13 μg·g-1 and 47.65-549.46 μg·g-1. Conclusion: This simple, stable, reliable and reproducible method can be used for the quality control of Zilian Shengji gel.

Cite this article

YAN Zhi-pan, LI Xi-xiang, GAO Li-xia . Establishment of HPLC fingerprints and determination of six components for Zilian Shengji gel*[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44(9) : 1586 -1596 . DOI: 10.16155/j.0254-1793.2023-0543

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