RESUMO
Aim: A method has been developed and validated for quantitation of selumetinib in human whole blood collected using a Mitra™ volumetric absorptive microsampling device. This device is patient-friendly, affording less-invasive sampling with broad applicability to clinical and diagnostic applications - specifically in pediatric populations. Materials & methods: In this method, drug is extracted from the Mitra device via sonication in methanol: Ammonium hydroxide, then analyzed by LC-MS/MS. The linear range for selumetinib analysis is 2.00-2000 ng/ml. Results: All validation parameters met acceptance criteria established in agreement with current regulatory guidance for bioanalytical method validation. The stability of selumetinib in Mitra tips was established at both ambient and frozen conditions. Conclusion: A simple method has been developed and validated for determination of selumetinib from human whole blood, collected using volumetric absorptive microsampling and analyzed by LC-MS/MS.
