| 17702193 |
Li XL, Li BY, Ni MY, Wang BJ, Guo RC: An improved HPLC method for determination of nifuratel in human plasma and its application to pharmacokinetics studies. Eur J Drug Metab Pharmacokinet. 2007 Apr-Jun;32(2):69-73.
A rapid, simple and sensitive high-performance liquid chromatography (HPLC) method was established for the quantification of nifuratel in human plasma and applied to a study of its pharmacokinetics. A test and a reference formulation were investigated and compared, and the study group consisted of 24 healthy male volunteers. The analytical technique was based on a single extraction of the drug from the plasma with chloroform, using ornidazole as internal standard (IS). The chromatographic system consisted of a 5-microm 4.6 mmX250 mm C18 analytical column and the mobile phase consisted of methanol and purified water (45:55, v/v). Nifuratel and ornidazole concentrations were detected by ultraviolet (UV) absorbance at a wavelength of 254 nm. The lower limit of detection and quantification was 0.5 ng ml (-1), and the calibration curves were linear over a concentration range of 0.5-160 ng ml (-1) nifuratel in the plasma. The results showed that the area under the plasma concentration-time curve (AUC), time to maximum observed plasma concentration (Tmax), maximum concentration reached in the concentration profile (Cmax), and elimination half-life (t1/2) between the test tablets and the reference tablets demonstrated no significant difference (P> 0.05). The relative bioavailability amounted to 103.13% +/-8.73%. |
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