Standard Deliberation

Standardization of Xiaokeling tablets based on assay and stoichiometric analysis

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  • Guangxi Institute for Food and Drug Control, Nanning 530021, China

Revised date: 2021-01-13

  Online published: 2024-05-31

Abstract

Objective: To establish a stoichiometric method for the quantitative evaluation of the active principle ingredients(API)in Rhizoma Coptidis, six alkaloids and paeonol, in 111 batches of Xiaokeling tablets produced by 13 manufactures. Methods: The assay method of alkaloids in Rhizoma Coptidis(afriline, epiberberine, jatrorrhizine hydrochloride, coptidine hydrochloride, palmatine hydrochloride and berberine hydrochloride)and paeonol in Xiaokeling tablets was established by HPLC-UV processed by the software Chempatten. Results: 7 components were separated well on baseline. The injection ranges were 6. 05-249 ng, 9. 29-226 ng, 5. 94-195 ng, 11. 0-283 ng, 9. 94-267 ng, 55. 4-1 847 ng and 23. 576-589. 410 ng, respectively, which were in good linear with the peak areas. The average recoveries met methodological requirements at 90. 0%, 84. 8%, 91. 9%, 90. 3%, 93. 1%, 93. 0% and 92. 3%, respectively. It indicated that stoichiometric assays were applicable for sample tracings. Conclusion: The above-mentioned method is proved to be simple, accurate, stable and repeatable, and showing referential significance for the quantitative standardization of Xiaokeling tablets.

Cite this article

LIN Yan-xiang, ZHANG Ying-ting, HUANG Bo, ZHANG Hui, YAO Li, LUO Yi, ZHU Xue-yan, XIE Pei-de . Standardization of Xiaokeling tablets based on assay and stoichiometric analysis[J]. Chinese Journal of Pharmaceutical Analysis, 2021 , 41(3) : 508 -514 . DOI: 10.16155/j.0254-1793.2021.03.17

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