@article{Vidal_GONCALINHO_Monteiro_NEVES_Sarmento_Diniz_FRESCO_2014, title={DEVELOPMENT AND VALIDATION OF A RAPID AND SIMPLE REVERSED-PHASE HPLC METHOD FOR THE DETERMINATION OF GEMCITABINE IN HUMAN PLASMA}, volume={6}, url={https://journals.innovareacademics.in/index.php/ijpps/article/view/3200}, abstractNote={<div><strong>Objective:</strong> In order to investigate the human plasma pharmacokinetics of dFdC, the objective of this work was to optimize and validate a rapid reversed-phase (RP) high-performance liquid chromatography (HPLC) method according to the guidelines of the international regulatory institutions: European Medicines Agency (EMA), Food and Drug Administration (FDA) and International Conference on Harmonization (ICH).</div> <div><strong>Methods:</strong> Chromatographic runs were performed on a RP-ACE-C18 column. Mobile phase was constituted of sodium acetate buffer (pH 5) and acetonitrile, in gradient mode, at a flow rate of 1 mL/min. Gemcitabine and cytarabine (internal standard) were detected at 290 nm.</div> <div><strong>Results:</strong> The method was shown to be selective, linear in the range of 0.25–10 mg/L (R2=0.9998), accurate and precise within-run and between-run as reflected by the coefficient of variation values (<15%) and the relative errors values (<15%), stable and robust to changes in the column temperature and detection UV wavelength. Detection limit and lower limit of quantification were 0.22 and 0.25 mg/L respectively.</div> <div><strong>Conclusion:</strong> The developed method is useful to measuring gemcitabine plasmatic concentrations in pharmacokinetics studies and in therapeutic drug monitoring.</div>}, number={9}, journal={International Journal of Pharmacy and Pharmaceutical Sciences}, author={Vidal, Hugo and GONCALINHO, HELENA and Monteiro, Joaquim and NEVES, JOSE DAS and Sarmento, Bruno and Diniz, Carmen and FRESCO, PAULA}, year={2014}, month={Sep.}, pages={59–65} }