Development and validation of an ion pair HPLC method for gemcitabine and 2′,2′-difluoro-2′-deoxyuridine determination |
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| Authors: | R Losa MI Sierra A Fernández D Blanco |
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| Institution: | a Laboratory of Medical Oncology, Instituto Universitario de Oncología del Principado de Asturias (IUOPA), Hospital Central de Asturias, Edificio Polivalente A, 3 planta, C/Julian Clavería s/n, 33006 Oviedo, Asturias, Spain
b Department of Physical and Analytical Chemistry, Chemistry Faculty, University of Oviedo, 33006 Oviedo, Spain |
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| Abstract: | A reverse phase HPLC method based on ion-pair formation was set up for the simultaneous determination of gemcitabine and its metabolite 2′,2′-difluoro-2′-deoxyuridine (dFdU) in plasma samples obtained from cancer patients. The separation was performed on a μBondapack C18 (300 mm × 3.9 mm i.d., 10 μm particle size) column at room temperature. The mobile phase, 5 mM pentane-1-sulfonic acid pH 3.1/methanol (96:4), was pumped at a flow rate of 1.5 mL min−1. Gemcitabine and dFdU eluted in less than 16 min. Linearity, sensitivity, and reproducibility studies, which actual values met the demands for bioanalytical assays, validated the method. This assay provided pharmacokinetic data from patients treated with intravenous gemcitabine. |
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| Keywords: | Gemcitabine dFdU Ion-pair HPLC Plasma Pharmacokinetics |
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