Development and validation of an ion pair HPLC method for gemcitabine and 2',2'-difluoro-2'-deoxyuridine determination [An article from: Analytica Chimica Acta]

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Description:
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 @mBondapack C"1"8 (300mmx3.9mm i.d., 10@mm particle size) column at room temperature. The mobile phase, 5mM pentane-1-sulfonic acid pH 3.1/methanol (96:4), was pumped at a flow rate of 1.5mLmin^-^1. Gemcitabine and dFdU eluted in less than 16min. 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.