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Absolute Quantum Yield Measurement of Powder Samples
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A convenient strategy to overcome interference in LC-MS/MS analysis: Application in a microdose absolute

Long Yuan1, Christine Huang2, Peggy Liu-Kreyche2

  • 1Bioanalytical Sciences, Bristol-Myers Squibb, Princeton, NJ, 08543, USA.

Journal of Pharmaceutical and Biomedical Analysis
|December 16, 2018
PubMed
Summary

A new strategy using isotopic ion monitoring in LC-MS/MS assays overcomes interference issues in microdose bioavailability studies. This method saves time and cost by simplifying stable isotope labeled (SIL) compound synthesis and enabling accurate bioanalysis.

Keywords:
BioanalysisInterferenceIsotopic contributionLC-MS/MSMicrodose absolute bioavailability studyQuantitativeStable isotopically labelled (SIL) compounds

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Area of Science:

  • Bioanalytical Chemistry
  • Pharmacokinetics
  • Mass Spectrometry

Background:

  • Stable isotope labeled (SIL) compounds are crucial internal standards (IS) for accurate liquid chromatography-mass spectrometry (LC-MS) bioanalytical assays.
  • Microdose absolute bioavailability (BA) studies increasingly use SIL drugs and LC-MS, offering cost and time savings over accelerator mass spectrometry (AMS).
  • A key challenge is potential interference between unlabeled drugs, microdose SIL drugs, and SIL-IS during LC-MS analysis.

Purpose of the Study:

  • To develop a cost-effective strategy to overcome LC-MS interference in microdose absolute bioavailability studies.
  • To enable the use of synthetically accessible SIL compounds for improved efficiency and reduced costs.
  • To support the accurate bioanalysis of BMS-986205 in dog and human plasma.

Main Methods:

  • Monitoring the isotopic ion (e.g., 37Cl) instead of the monoisotopic ion of the interfered compound during MS analysis.
  • Development of a LC-MS/MS assay for simultaneous analysis of BMS-986205 and its microdose SIL counterpart using a specific SIL-IS.
  • Validation of the assay in dog and human plasma.

Main Results:

  • A 90-fold reduction in interference was achieved by monitoring the 37Cl ion for the SIL-IS analysis.
  • The strategy enabled the use of a simpler, synthetically accessible SIL compound, accelerating the BA study.
  • The developed LC-MS/MS assay was successfully applied to microdose absolute BA studies in dogs and humans.
  • The method also demonstrated potential to reduce analyte MS response, preventing detector saturation.

Conclusions:

  • The isotopic ion monitoring strategy effectively resolves LC-MS interference in microdose BA studies.
  • This approach significantly reduces synthesis complexity and costs associated with SIL compounds.
  • The strategy is broadly applicable to various compounds and other bioanalytical applications, including IS selection.