title: Stability study of Prulifloxacin and Ulifloxacin in human plasma by HPLC-DAD.
abstract: A new and specific HPLC-DAD method for the direct determination of Prulifloxacin and its active metabolite, Ulifloxacin, in human plasma has been developed. Plasma samples were analysed after a simple solid phase extraction (SPE) clean-up using a new HILIC stationary phase based high-performance liquid chromatography (HPLC) column and an ammonium acetate buffer (5 mM, pH 5.8)/acetonitrile (both with 1% Et(3)N, v/v) mobile phase in isocratic elution mode, with Danofloxacin as the internal standard. Detection was performed using DAD from 200 to 500 nm and quantitative analyses were carried out at 278 nm. The LOQ of the method was 1 μg/mL of the cited analytes and the calibration curve showed a good linearity up to 25 μg/mL. For both analytes the precision (RSD%) and the trueness (bias%) of the method fulfil with International Guidelines. The method was applied for stability studies, at three QC concentration levels, in human plasma samples stored at different temperature of + 25, + 4 and -20 °C in order to evaluate plasma stability profiles.
authors: a Department of Pharmacy , University "G. d'Annunzio" Chieti-Pescara , Chieti , Italy and.|b Interuniversity Consortium of Structural and Systems Biology , Viale Medaglie d'oro 305 , Roma , Italy.
authors: Marcello
authors: M
authors: Locatelli
authors: a Department of Pharmacy , University "G. d'Annunzio" Chieti-Pescara , Chieti , Italy and.
authors: Roberta
authors: R
authors: Cifelli
authors: a Department of Pharmacy , University "G. d'Annunzio" Chieti-Pescara , Chieti , Italy and.
authors: Giuseppe
authors: G
authors: Carlucci
authors: a Department of Pharmacy , University "G. d'Annunzio" Chieti-Pescara , Chieti , Italy and.
authors: Annalisa
authors: A
authors: Romagnoli
mesh_terms: D002851:Chromatography, High Pressure Liquid; D004148:Dioxolanes / Q000097:blood*; D004355:Drug Stability; D024841:Fluoroquinolones / Q000097:blood*; D006801:Humans; D015394:Molecular Structure; D010879:Piperazines / Q000097:blood*; D052616:Solid Phase Extraction; D059005:Topoisomerase II Inhibitors / Q000097:blood*
chemical_list: D004148:Dioxolanes; D024841:Fluoroquinolones; D010879:Piperazines; D059005:Topoisomerase II Inhibitors; C074190:ulifloxacin; C074191:prulifloxacin
keywords: Extraction procedure; HPLC–DAD; Prulifloxacin; Ulifloxacin; stability profile