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Related Experiment Video

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Simultaneous Determination of Ripretinib and Its Desmethyl Metabolite in Human Plasma Using LC-MS/MS.

Zhou-Yi Qian1, Ping Wang1, Zi-Yi Wang1

  • 1Research Division of Clinical Pharmacology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China ; and.

Therapeutic Drug Monitoring
|August 8, 2024
PubMed
Summary

A new method accurately measures ripretinib and its metabolite DP-5439 in plasma. This validated assay supports the clinical development of ripretinib for gastrointestinal stromal tumors.

Keywords:
DP-5439human plasmaripretinibtandem mass spectrometry

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Area of Science:

  • Pharmacology
  • Analytical Chemistry
  • Oncology

Background:

  • Ripretinib is a tyrosine kinase inhibitor targeting KIT and PDGFRA mutants.
  • These mutations drive gastrointestinal stromal tumor (GIST) progression.
  • Understanding ripretinib pharmacokinetics is crucial for its clinical application.

Purpose of the Study:

  • To develop and validate a high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method.
  • To quantify ripretinib and its active metabolite DP-5439 in human plasma.
  • To support the clinical development of ripretinib in oncology.

Main Methods:

  • Human plasma samples were processed via acetonitrile precipitation.
  • Ripretinib and DP-5439 were separated using UPLC HSS T3 column chromatography.
  • Gradient elution with formic acid/ammonium formate and acetonitrile was employed.

Main Results:

  • The method demonstrated linearity over wide concentration ranges (7.5–3000 ng/mL for ripretinib, 10–4000 ng/mL for DP-5439).
  • Intraday and interday precision were within acceptable limits (approx. 15%).
  • Acceptable relative matrix effects (90.3%–108.8%) were observed.

Conclusions:

  • A validated HPLC-MS/MS method for ripretinib and DP-5439 in human plasma was established.
  • This analytical method is suitable for supporting further clinical trials of ripretinib.
  • The assay facilitates pharmacokinetic studies essential for ripretinib's development.