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Rapid and Sensitive High Performance Liquid Chromatographic Determination of Zonisamide in Human Serum Application to a Pharmacokinetic Study

An accurate and very rapid method for determination of zonisamide an antiepileptic drug, in human serum is described. The analytical procedure involves liquid-liquid extraction of the analyte and an internal standard (vanillin) from human serum by ethyl acetate as extracting solvent. Chromatographic...

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Detalles Bibliográficos
Autores principales: Majnooni, M. B., Mohammadi, B., Jalili, R., Bahrami, G. H.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3630733/
https://www.ncbi.nlm.nih.gov/pubmed/23626393
http://dx.doi.org/10.4103/0250-474X.107073
Descripción
Sumario:An accurate and very rapid method for determination of zonisamide an antiepileptic drug, in human serum is described. The analytical procedure involves liquid-liquid extraction of the analyte and an internal standard (vanillin) from human serum by ethyl acetate as extracting solvent. Chromatographic separation was achieved using a monolithic C18 analytical column and a mixture of 0.05 M phosphate buffer containing triethylamine (1 ml/l; pH 2.7) and methanol (83:17 v/v) was used as the mobile phase. The detection wavelength was set at 240 nm. The calibration curve was linear over a concentration range of 0.015-6.4 μg/ml of zonisamide in human serum. The total run time of analysis was 3.5 min and the lower limits of detection and quantification were 0.005 and 0.015 μg/ml, respectively. The method validation was carried out in terms of specificity, sensitivity, linearity, precision, accuracy and stability. The validated method was applied in a randomised crossover bioequivalence study of two different zonisamide preparations in 24 healthy volunteers, and the assay was sensitive enough to measure drug levels up to 8 days following a single dose administration of zonisamide.