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  • Title: Development and validation of a method for gefitinib quantification in dried blood spots using liquid chromatography-tandem mass spectrometry: Application to finger-prick clinical blood samples of patients with non-small cell lung cancer.
    Author: Irie K, Shobu S, Hiratsuji S, Yamasaki Y, Nanjo S, Kokan C, Hata A, Kaji R, Masago K, Fujita S, Okada Y, Katakami N, Fukushima S.
    Journal: J Chromatogr B Analyt Technol Biomed Life Sci; 2018 Jun 15; 1087-1088():1-5. PubMed ID: 29689441.
    Abstract:
    A liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed and validated for the quantification of gefitinib in dried blood spots (DBSs). Gefitinib was extracted with methanol from DBS of 3 mm in diameter and detected using a triple quadrupole mass spectrometer. The method was validated by evaluating its precision, accuracy, selectivity, carryover, matrix effect, recovery, and stability. For clinical validation, paired finger-prick DBS and plasma concentrations were compared for 10 patients with non-small cell lung cancer (NSCLC) taking gefitinib. The calibration linear range was 37.5-2400 ng/mL (coefficient of determination [R2] = 0.99), encompassing the therapeutic concentrations of gefitinib. The accuracy and precision were within 15% of the quality control (QC) concentrations of 80, 200, and 2000 ng/mL. The lower limit of quantification was determined to be 40 ng/mL. Gefitinib was stable in DBSs for up to 5 months at room temperature and -20 °C, and at 40 °C for 24 h. A good correlation was observed between the gefitinib levels measured by the DBS method and plasma concentrations (R2 = 0.99). This method provides a simple, fast, and accurate approach to the quantitative analysis of gefitinib in finger-prick DBSs. The method would be useful for minimally invasive evaluation of the clinical gefitinib blood concentration.
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