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A high performance liquid chromatography method for the quantitative
determination of ribavirin in human plasma and its application in a pharmacokinetics study

Hua Zhang, Guiling Wang, Kexin Li, Xuan Zhang*, Qiang Zhang   

  1. 1. Department of Pharmaceutics, School of Pharmaceutical Sciences, Peking University Health Science Center, Beijing 100191, China
    2. Department of Pharmacy, Beijing Hospital, Ministry of Health, Beijing 100730, China
  • Received:2012-10-09 Revised:2012-11-19 Online:2013-07-10 Published:2013-07-10
  • Contact: Xuan Zhang*

Abstract:

The clinical pharmacokinetics of ribavirin after a single oral dose of 600 mg ribavirin tablets in healthy Chinese volunteers was studied. A rapid and simple high performance liquid chromatography (HPLC) method was developed to determine the ribavirin concentration in human plasma. C18 column was used for separation with a column temperature of 25 °C, the mobile phase was ultrapure water adjusted to pH 3 with acetic acid at the flow rate of 1 mL/min, and the detection wavelength was set at 207 nm. The linear range of the standard curves was 50.4-2016.0 ng/mL and the lower limit of quantification (LLOQ) was 50.4 ng/mL. The relative recoveries of ribavirin were more than 90% in plasma. The RSD of the intra-day precision was less than 10% and that of inter-day was less than 15%. The pharmacokinetic parameters of ribavirin were calculated by WinNonlin. Results indicated that the two-compartment model was a better model for describing the pharmacokinetics profile of ribavirin than one-compartment model. The AUC0-t was 10807.8 h∙ng/mL, the CL/F was 64879.5 mL, and the Cmax was 525.1 ng/mL. These results provided the experimental data for the development of ribavirin dosage form.

Key words: Ribavirin, HPLC, Pharmacokinetics, Compartmental model

CLC Number: 

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