Abstract
A high performance liquid chromatography method had been developed and validated for rapid simultaneous separation and determination of three anti-helicobacter drugs, oxytetracycline (OXY), tinidazole (TIN) and esomeprazole (ESM) in human plasma within 6minutes. Drugs extraction method from plasma was based on protein precipitation technique. Separation was carried out on a Equisil BDS C18 column (5μm, 150×4.60mm) using a mobile phase of acetonitrile: 0.025M KH2PO4 (25: 75, v/v) adjusted to pH3.50 with ortho-phosphoric acid at ambient temperature. The flow rate was 1mL/min and maximum absorption was measured using Diode Array (DAD) detector at 285nm. The retention times of OXY, TIN and ESM were recorded to be 2.68, 3.52 and 5.17minutes, respectively, indicating a shorter analysis time. Limits of detection were also reported to be 0.10, 0.07 and 0.04μg/mL for OXY, TIN and ESM, respectively, showing a high degree of the method sensitivity. The method was then validated according to FDA guidelines for the determination of the drugs clinically in human plasma specially regarding pharmacokinetic and bioequivalence studies.
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