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Optimized LC-MS/MS Method for the High-throughput Analysis of Clinical Samples of Ivacaftor, Its Major Metabolites, and Lumacaftor in Biological Fluids of Cystic Fibrosis Patients
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Volumetric absorptive microsampling for lumateperone analysis: method validation and stability evaluation.

Elisa Milandri1, Roberta Di Lecce2, Chiara Pia Iattoni1

  • 1Research Group of Pharmaco-Toxicological Analysis (PTA Lab), Department of Pharmacy and Biotechnology (FaBiT), Alma Mater Studiorum - University of Bologna, Via Belmeloro 6, 40126, Bologna, Italy.

Analytical and Bioanalytical Chemistry
|November 18, 2025
PubMed
Summary
This summary is machine-generated.

This study introduces a novel microsampling method for analyzing lumateperone, an antipsychotic. This approach supports therapeutic drug monitoring (TDM) for personalized psychiatric treatment, improving patient adherence and reducing side effects.

Keywords:
HPLC–MS/MSLumateperoneMethod development and validationMicrosamplingSolid-phase extraction (SPE)Volumetric absorptive microsampling (VAMS)

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Area of Science:

  • Pharmacology
  • Analytical Chemistry
  • Clinical Diagnostics

Background:

  • Lumateperone is an atypical antipsychotic for schizophrenia with moderate side effects.
  • Therapeutic drug monitoring (TDM) is crucial for personalized treatment and reducing toxicity risks, especially with multidrug coadministration.
  • Microsampling offers advantages for TDM, including minimally invasive collection, enhanced analyte stability, and simplified logistics.

Purpose of the Study:

  • To develop and validate a microsampling-based analytical method for lumateperone quantification.
  • To compare the performance of volumetric absorptive microsampling (VAMS) with traditional plasma analysis for lumateperone.
  • To support future TDM applications for psychiatric patients treated with lumateperone.

Main Methods:

  • Development and validation of a high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method.
  • Utilized volumetric absorptive microsampling (VAMS) for capillary blood collection.
  • Compared VAMS results with standard in-tube fluid plasma analysis and conducted stability assays.

Main Results:

  • A reliable and streamlined VAMS protocol was optimized for lumateperone analysis.
  • The HPLC-MS/MS method demonstrated satisfactory linearity, precision, extraction yield, and matrix effect.
  • VAMS performance was comparable to plasma analysis, with enhanced analyte stability observed in dried microsamples.

Conclusions:

  • This is the first validated microsampling method for lumateperone analysis, offering reliable data comparable to plasma analysis.
  • The developed VAMS method presents significant advantages over conventional blood sampling for collection, storage, and processing.
  • The method shows promise for future TDM applications in patients receiving lumateperone therapy.