Desenvolvimento e validação de método analítico com utilização de dessorção térmica de laser de diodo acoplado a espectrometria de massas para aplicação em um estudo de bioequivalência de lamotrigina

Abstract

Introduction: Lamotrigine is a widely used antiepileptic drug, and monitoring plasma levels is essential in bioequivalence studies. Conventional methods of liquid chromatography coupled to triple quadrupole mass spectrometry require complex sample preparation and long analysis times. Thus, the development of fast and robust alternatives is justified, such as laser diode thermal desorption coupled to triple quadrupole mass spectrometry for application in drug quantification. Objective: he objective of this work is to develop and use a laser diode thermal desorption method coupled to triple quadrupole mass spectrometry in a bioequivalence study of lamotrigine. Methods: Extraction tests, laser source adjustments, application of modern tests for stability evaluation and analytical validation were carried out, with application in real samples from research participants. Results and Discussions: The developed method showed simple extraction from only 50 μL of plasma using carbamazepine as the internal standard, high reproducibility, and extremely reduced analysis time (10 seconds per sample). There was elimination of excessive solvent use, a significant reduction in the total analytical stage time, elimination of the need for chromatographic column use, no matrix effect, while maintaining the robustness of the bioequivalence assay. Conclusion: The pharmacokinetic parameters obtained were consistent with literature data, demonstrating that the laser diode thermal desorption technique can replace liquid chromatography with greater efficiency and speed when coupled to mass spectrometry, without compromising the quality of the results.