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Schwalb, L. ; Tiemann, O.* ; Käfer, U. ; Gröger, T.M. ; Rüger, C.P.* ; Gayko, G.* ; Zimmermann, R.

Analysis of complex drugs by comprehensive two-dimensional gas chromatography and high-resolution mass spectrometry: Detailed chemical description of the active pharmaceutical ingredient sodium bituminosulfonate and its process intermediates.

Anal. Bioanal. Chem., DOI: 10.1007/s00216-022-04393-w (2022)
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The European pharmacopeia provides analytical methods for the chemical characterization of active pharmaceutical ingredients (APIs). However, the complexity of some APIs exceeds the limitations of the currently prevailing physicochemical methods. Sodium bituminosulfonate (SBS) is described by the collection of key parameters of generalizing criteria such as dry matter, sulfur and sodium content, and neutrality, but techniques to unravel the complexity on a molecular level are lacking. We present a study based on online derivatization with tetramethylammonium hydroxide in combination with comprehensive two-dimensional gas chromatography coupled to an electron ionization high-resolution time-of-flight mass spectrometer (GC × GC-HR-ToF–MS) for the chemical description of SBS as well as its process intermediates. The application of GC × GC allowed the comprehensive description of the chemical components in the API and the process intermediates for the first time. Furthermore, it was possible to classify peaks regarding their elemental and structural composition based on accurate mass information, elution behavior, and mass fragmentation pattern. This work demonstrates not only the general applicability, advantages but also limitations of GC × GC for the characterization of APIs for complex drugs. Graphical Abstract: [Figure not available: see fulltext.]
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Publication type Article: Journal article
Document type Scientific Article
Keywords Classification ; Complex Drugs ; Gc × Gc ; Hr-ms ; Non-biological Complex Drugs ; Sodium Bituminosulfonate
Language english
Publication Year 2022
HGF-reported in Year 2022
ISSN (print) / ISBN 1618-2642
e-ISSN 1618-2650
Journal Analytical and Bioanalytical Chemistry
Publisher Springer
Publishing Place Heidelberg
Reviewing status Peer reviewed
Institute(s) Cooperation Group Comprehensive Molecular Analytics (CMA)
POF-Topic(s) 30202 - Environmental Health
Research field(s) Environmental Sciences
PSP Element(s) G-504500-001
Grants Ichthyol-Gesellschaft Cordes, Hermanni & Co. (GmbH & Co.) KG
DOI 10.1007/s00216-022-04393-w
WOS ID WOS:000885412800001
Scopus ID 85142222407
PubMed ID 36401638
Erfassungsdatum 2022-12-07
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