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Please use this identifier to cite or link to this item: http://hdl.handle.net/123456789/18756

Title: - HPLC Separation Technique for Analysis of Bufuralol enantiomers in Plasma and
Authors: M. Hefnawy, Mohamed.
A. Sultan, Maha.
M.El-Shehry, Mona.
Keywords: Bufuralol enantiomers, vancomycin chiral stationary phase, plasma
Issue Date: 2007
Publisher: Elsevier
Citation: Journal of Chromatography B, 856, 328-336,
Abstract: A sensitive and selective high-performance liquid chromatographic (HPLC) method has been developed for the simultaneous determination of bufuralol enantiomers in plasma and pharmaceutical formulations. Enantiomeric resolution was achieved on a vancomycin macrocyclic antibiotic chiral stationary phase (CSP) known as Chirobiotic V with UV detection set at 254 nm. The polar ionic mobile phase (PIM) consisting of methanol–glacial acetic acid–triethylamine (100:0.015:0.010, v/v/v) has been used at a flow rate of 0.5 ml/min. The method is highly specific where other coformulated compounds did not interfere. The stability of bufuralol enantiomers under different degrees of temperature was also studied. The results showed that the drug is stable for at least 7 days at 70 ◦C. The method was validated for its linearity, accuracy, precision and robustness. An experimental design was used during validation to evaluate method robustness. The calibration curves in plasma were linear over the range of 5–500 ng/ml for each enantiomer with detection limit of 2 ng/ml. The mean relative standard deviation (RSD) of the results of within-day precision and accuracy of the drug were ≤10%. There was no significant difference (p > 0.05) between inter- and intra-day studies for each enantiomer which confirmed the reproducibility of the assay method.
URI: http://hdl.handle.net/123456789/18756
ISSN: 1570-0232
Appears in Collections:College of Pharmacy

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