HPLC Method for Quantification of Ornidazole in Human Plasma

Abstract

A sensitive and rapid reverse phase HPLC method was   developed to quantify plasma levels of ornidazole, to evaluate   a comparative bioavailability study. The drug and internal   standard were purified from plasma samples by liquid-liquid   extraction using dichloromethane. The HPLC separation was   performed on BDS hypersil C₁₈ column (250 × 4.6 mm, 5 μ),   using 0.05 M disodium hydrogen phosphate (pH 4.8) and   acetonitrile (60:40 v/v) with a flow rate of 1 mL/min and UV   detection at 313 nm. Standard curve covering 50 ng-12 μg/mL   concentration range, was linear (r² = 0.9997). The precision   and accuracy of ornidazole was 3.52 > % RSD and 3.6 > %   RME in intra-day and inter-day analysis after four quality   control very low, low, medium and high (QCVL, QCL, QCM   and QCH) samples. The bio-study was carried out in 12   healthy human volunteers according to a single dose, twosequence,   cross over randomized design. The 90 % confidence   interval for the ratio of the logarithmic transformed AUC_0-∞   (0.83-1.02) and Cmax (0.93-1.03) were within the bioequivalence   limit of 0.80-1.25.