DEVELOPMENT AND VALIDATION OF A RAPID AND SIMPLE REVERSED-PHASE HPLC METHOD FOR THE DETERMINATION OF GEMCITABINE IN HUMAN PLASMA
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2014, Vol 6, Issue 9
Abstract
Objective: 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). Methods: 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.Results: 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.  Conclusion: The developed method is useful to measuring gemcitabine plasmatic concentrations in pharmacokinetics studies and in therapeutic drug monitoring. Objective: 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).Methods: 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.Results: 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. Conclusion: The developed method is useful to measuring gemcitabine plasmatic concentrations in pharmacokinetics studies and in therapeutic drug monitoring.
Authors and Affiliations
Hugo Vidal, Helena GonÇalinho, Joaquim Monteiro, JosÉ Das Neves, Bruno Sarmento, Carmen Diniz, Paula .
Keywords
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