An improved HPLC method for determination of nifuratel in human plasma and its application to pharmacokinetics studies.
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%.
Li
Xiao-Li
XL
Institute of Clinical Pharmacology, Qi-Lu Hospital of Shandong University, Jinan, Shandong Province, The People's Republic of China.
Li
Bao-Ying
BY
Ni
Mei-Yuan
MY
Wang
Ben-Jie
BJ
Guo
Rui-Chen
RC
D000704:Analysis of Variance; D000935:Antifungal Agents / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D002138:Calibration; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D018592:Cross-Over Studies; D004355:Drug Stability; D004356:Drug Storage; D005615:Freezing; D006207:Half-Life; D006801:Humans; D008297:Male; D009545:Nifuratel / Q000493:pharmacokinetics*; D009950:Ornidazole / Q000097:blood; D012015:Reference Standards; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet
D000935:Antifungal Agents; D009950:Ornidazole; D009545:Nifuratel
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