Discrepancies in the German Pharmacopoeia procedure for quality control of Quillaja saponin extracts.

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Tytuł:: Discrepancies in the German Pharmacopoeia procedure for quality control of Quillaja saponin extracts.
Autorzy:: Thalhamer B; Institute of Analytical Chemistry, Johannes-Kepler University, Linz, Austria.
Buchberger W; Institute of Analytical Chemistry, Johannes-Kepler University, Linz, Austria.
Źródło:: Archiv der Pharmazie [Arch Pharm (Weinheim)] 2021 Dec; Vol. 354 (12), pp. e2100262. Date of Electronic Publication: 2021 Sep 17.
Typ publikacji:: Journal Article
Język:: English
Imprint Name(s):: Publication: <2005->: Weinheim Germany : Wiley-VCH Verlag GmbH & Co. KGaA
Original Publication: Weinheim, Verlag Chemie GmbH.
MeSH Terms:: Quality Control*
Plant Extracts/*analysis
Quillaja Saponins/*analysis
Chromatography, High Pressure Liquid ; Germany ; Madhuca/chemistry ; Mass Spectrometry ; Pharmacopoeias as Topic ; Plant Extracts/standards ; Quillaja Saponins/standards
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Contributed Indexing:: Keywords: German Pharmacopoeia 9th ed.; Madhuca longifolia; Quillaja saponin extract; adulteration; pharmacopoeial quality control
Substance Nomenclature:: 0 (Plant Extracts)
0 (Quillaja Saponins)
Entry Date(s):: Date Created: 20210917 Date Completed: 20220302 Latest Revision: 20220302
Update Code:: 20240105
DOI:: 10.1002/ardp.202100262
PMID:: 34533846
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This study focused on the evaluation of Quillaja saponin extracts with the additional quality designation DAB-which means the abbreviation of the German Pharmacopoeia (Deutsches Arzneibuch). This label suggests that Quillaja saponin extracts marked in this way are of pharmacopoeial quality and thus stand out from other Quillaja saponin extracts. The DAB ninth edition listed Quillaia saponin as a reagent. According to DAB, its quality must be checked by thin-layer chromatography (TLC), and three closely spaced zones in a defined retention factor (Rf) interval specify the saponin reagent. All the Quillaja saponin extracts obtained from different manufacturers and labeled as DAB quality complied with the TLC test. However, the analysis with high-performance liquid chromatography-quadrupole time-of-flight-mass spectrometry (HPLC-Q-ToF-MS) clearly showed additionally an intense peak pattern of Madhuca saponins in all measured samples. The TLC test for Mahua seed cake, which is the press residue from Madhuca longifolia, surprisingly showed the same three closely spaced zones in the defined Rf interval. The three zones could be identified as Mi-saponins from Madhuca after scraping and extracting them from the stationary phase of the TLC plate and subsequent measurement by HPLC-Q-ToF-MS. Therefore, the specification of the saponin reagent in DAB characterizes erroneously Madhuca saponins that are not listed as a saponin plant source for the saponin reagent.
(© 2021 The Authors. Archiv der Pharmazie Published by Wiley-VCH Verlag GmbH on behalf of Deutsche Pharmazeutische Gesellschaft.)

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