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HPLC-UV analytical method for determination of pizotifen after in vitro transdermal diffusion studies

Authors

  • C. E. Serna-Jiménez,

    Corresponding author
    • Departamento de Fisiología, Farmacología y Toxicología, Facultad de Ciencias de la Salud, Universidad CEU Cardenal Herrera, Moncada, Valencia, Spain
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  • S. del Rio Sancho,

    1. Departamento de Fisiología, Farmacología y Toxicología, Facultad de Ciencias de la Salud, Universidad CEU Cardenal Herrera, Moncada, Valencia, Spain
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  • M. A. Calatayud-Pascual,

    1. Departamento de Fisiología, Farmacología y Toxicología, Facultad de Ciencias de la Salud, Universidad CEU Cardenal Herrera, Moncada, Valencia, Spain
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  • C. Balaguer-Fernández,

    1. Departamento de Fisiología, Farmacología y Toxicología, Facultad de Ciencias de la Salud, Universidad CEU Cardenal Herrera, Moncada, Valencia, Spain
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  • A. Femenía-Font,

    1. Departamento de Fisiología, Farmacología y Toxicología, Facultad de Ciencias de la Salud, Universidad CEU Cardenal Herrera, Moncada, Valencia, Spain
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  • A. López-Castellano,

    1. Departamento de Fisiología, Farmacología y Toxicología, Facultad de Ciencias de la Salud, Universidad CEU Cardenal Herrera, Moncada, Valencia, Spain
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  • V. Merino

    1. Instituto de Reconocimiento Molecular y Desarrollo Tecnológico, Centro Mixto Universidad Politécnica de Valencia-Universidad de Valencia. Departamento de Farmacia y Tecnología Farmacéutica, Universidad de Valencia, Burjassot, Valencia, Spain
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C. E. Serna-Jiménez, Departamento de Fisiología, Farmacología y Toxicología, Facultad de Ciencias de la Salud, Universidad CEU Cardenal Herrera, Ed. Seminario s/n, 46113 Moncada, Valencia, Spain. E-mail: cesar.serna@uch.ceu.es

ABSTRACT

Pizotifen malate is an antihistamine and serotonin inhibitor used in the preventive treatment of migraine and eating disorders. A simple, rapid, accurate and precise high-performance liquid chromatography (HPLC) method involving ultraviolet detection was validated for the quantitative analysis of pizotifen malate in samples from in vitro transdermal diffusion studies. The method was validated for specificity, linearity, accuracy, precision, limit of detection, limit of quantification and robustness. Drug stability in the solution was also determined under different conditions. Separation was carried out using a 250 × 4.0 mm Kromasil® C18 column at room temperature. The detector response, fitted at 254 nm, was found to be linear in a concentration range between 0.24 and 24.0 µg/mL. The limit of detection was 0.02 µg/mL and the limit of quantification was 0.07 µg/mL. Finally, in vitro transdermal diffusion of pizotifen malate was characterized using the validated HPLC method. Copyright © 2011 John Wiley & Sons, Ltd.

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