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@ARTICLE{Jonas:1055046,
      author       = {Jonas, Alissa and Gering, Ian and Schartmann, Elena and
                      Schemmert, Sarah and Willbold, Dieter and Santiago-Schübel,
                      Beatrix and Kutzsche, Janine},
      title        = {{D}evelopment and {V}alidation of an
                      {UHPLC}-{ESI}-{QTOF}-{MS} {M}ethod {A}ccording to the {ICH}
                      {M}10 {G}uideline for {Q}uantification of the {C}linical
                      {D}rug {C}andidate {RD}2 in the {M}ouse {B}rain},
      journal      = {Analytica},
      volume       = {7},
      number       = {1},
      issn         = {2673-4532},
      address      = {Basel},
      publisher    = {MDPI},
      reportid     = {FZJ-2026-01838},
      pages        = {15 -},
      year         = {2026},
      abstract     = {The all-D-enantiomeric-peptide RD2 was developed for the
                      treatment of Alzheimer’s disease. This study aimed to
                      develop a specific and highly sensitive liquid
                      chromatographymass-spectrometric (UHPLC-ESI-QTOF) method for
                      quantifying RD2 in the mouse brainand to validate it
                      according to the ICH M10 guideline to investigate the
                      pharmacokinetic profile of RD2 in its target organ. Sample
                      preparation, chromatographic separation and quantification
                      were very challenging due to RD2’s highly hydrophilic
                      properties, the complex matrix and the required lower limit
                      of quantification (LLOQ). Chromatographic separation was
                      performed on an Acquity UPLC BEH C18 column (2.1 × 100 mm,
                      1.7 μm particle size) within 5 min at 50 ◦C with a flow
                      rate of 0.5 mL·min−1. Mobile phasesconsisted of water and
                      acetonitrile with $0.2\%$ formic acid and $0.015\%$
                      heptafluorobutyric acid. Ions were generated by electrospray
                      ionization in the positive mode, and RD2 was quantified by
                      QTOF-MS. The developed extraction method revealed complete
                      recovery.The linearity of the calibration curve was in the
                      range of 2 ng·mL−1 to 500 ng·mL−1 (R2 > 0.99) with a
                      LLOQ of 5 ng·mL−1. The intraday and interday accuracy and
                      precision ranged from $0.4\%$ to $12.2\%$ and from $1.0\%$
                      to $12.0\%.$ RD2 remained stable in thefreshly homogenized
                      brain even after several freeze–thaw cycles, but stability
                      decreased over time during long-term storage at −80 ◦C.
                      Using this validated method, RD2-spiked brain homogenate
                      samples and samples of a pharmacokinetic study with RD2 in
                      micewere analyzed.},
      cin          = {IBI-7},
      ddc          = {540},
      cid          = {I:(DE-Juel1)IBI-7-20200312},
      pnm          = {5244 - Information Processing in Neuronal Networks
                      (POF4-524)},
      pid          = {G:(DE-HGF)POF4-5244},
      typ          = {PUB:(DE-HGF)16},
      doi          = {10.3390/analytica7010015},
      url          = {https://juser.fz-juelich.de/record/1055046},
}