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Characterization of Sugammadex-Related Isomeric Cyclodextrin Impurities Using Cyclic Ion Mobility High-Resolution

Péter S Szakály1,2,3, Dávid Papp1,3, Arnold Steckel3

  • 1Hevesy György PhD School of Chemistry, ELTE Eötvös Loránd University, Institute of Chemistry, Pázmány Péter sétány 1/A, H-1117 Budapest, Hungary.

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Cyclic ion mobility-mass spectrometry effectively separated four regioisomers of a Sugammadex impurity (Di-OH-SGM). This advanced technique, coupled with mass spectrometry, provides high resolution for complex mixture analysis.

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Area of Science:

  • Analytical Chemistry
  • Separation Science
  • Mass Spectrometry

Background:

  • Cyclic ion mobility-mass spectrometry (cIM-MS) offers powerful multidimensional separation for isomeric mixtures.
  • Coupling cIM-MS with chromatography enhances resolving power and peak capacity.

Purpose of the Study:

  • To achieve separation and identification of four regioisomers of a Sugammadex-related impurity, Di-OH-SGM.
  • To explore the utility of cIM-MS for resolving complex isomeric mixtures.

Main Methods:

  • Multipass cyclic ion mobility was used, focusing on the [M + 2Na]2+ ion for optimal separation.
  • Two ion mobility separation methods (conventional multipass and slicing) were developed.
  • High-resolution mass spectrometry and characteristic fragment ions were employed for isomer identification.

Main Results:

  • Successful separation of four Di-OH-SGM regioisomers using cIM-MS.
  • Determination of collision cross section values (cTWCN2) for the resolved cyclodextrin isomers.
  • Demonstration of ion mobility separation for structurally distinct fragment ions.

Conclusions:

  • cIM-MS is effective for separating and identifying regioisomers of Sugammadex impurities.
  • Two-dimensional separation using HPLC-cIM-MS provided insights into isomer hydrophobicity.
  • The study highlights the capability of cIM-MS in complex analytical challenges.