Journal: |
Acta Chromatographica
Academia Kiado (Aki journals)
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Keywords : |
, , , , RP-HPLC-UV method , , analysis , oxcarbazepine , , presence , , preservatives;
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Abstract: |
A simple, sensitive, selective, accurate and precise method was developed and fully validated for
determination of oxcarbazepine (OXC) in presence of their preservatives and determination of oxcar-
bazepine (OXC) in human plasma. A reversed phase liquid chromatography (RP-HPLC) with UV
detection techniques were applied for separation and quantification of studied drug OXC. Successful
separation of the drug from methyl paraben (M.P.), propyl paraben (P.P.) and potassium sorbate (P.ST.)
was achieved on a Kromasil C18 column (5 μm particle size, pore size 300 Å, l 3 I.D. 250 3 4.6 mm).
The mobile phase that contain aqueous 0.05M potassium dihydrogen phosphate buffer (pH 7):
acetonitrile, (50: 50, %v/v). The method was linear over concentration ranges 5.0–50 μg mL1 for OXC.
Bioanalytical validation of the developed method was carried out according to US-FDA guidelines and
revealed a good linear relations over a range of (5.0–50), (0.5–10), (0.05–0.15), and (1.0–10) μg mL1 for
OXC, M.P, P.P, and P.ST, respectively, with a correlation coefficient (R2) of more than 0.999. Limit of
detection (LOD) were 1.15, 0.03, 0.01 and 0.04 μg mL1 for OXC, M.P, P.P, and P.ST, respectively,
Intra and inter-day precisions, calculated as percentage relative standard deviation (% RSD), were lower
than 2.0%. The developed method can be applied for routine drug analysis, therapeutic drug monitoring
and bioequivalence studies through the analysis of plasma samples taken from blood bank
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