The Validation of Plasma Darunavir Concentrations Determined by the HPLC Method for Protease Inhibitors

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  • Takahashi Masaaki
    Department of Pharmacy, National Hospital Organization Nagoya Medical Center (Tokai Area Central Hospital for AIDS Treatment and Research) Clinical Research Center, National Hospital Organization Nagoya Medical Center (Tokai Area Central Hospital for AIDS Treatment and Research)
  • Kudaka Yuichi
    Department of Pharmacy, National Hospital Organization Nagoya Medical Center (Tokai Area Central Hospital for AIDS Treatment and Research) Clinical Research Center, National Hospital Organization Nagoya Medical Center (Tokai Area Central Hospital for AIDS Treatment and Research)
  • Okumura Naoya
    Department of Pharmacy, National Hospital Organization Nagoya Medical Center (Tokai Area Central Hospital for AIDS Treatment and Research) Clinical Research Center, National Hospital Organization Nagoya Medical Center (Tokai Area Central Hospital for AIDS Treatment and Research)
  • Hirano Atsushi
    Department of Pharmacy, National Hospital Organization Nagoya Medical Center (Tokai Area Central Hospital for AIDS Treatment and Research) Clinical Research Center, National Hospital Organization Nagoya Medical Center (Tokai Area Central Hospital for AIDS Treatment and Research)
  • Banno Kazuhide
    Department of Pharmacy, National Hospital Organization Nagoya Medical Center (Tokai Area Central Hospital for AIDS Treatment and Research)
  • Kaneda Tsuguhiro
    Clinical Research Center, National Hospital Organization Nagoya Medical Center (Tokai Area Central Hospital for AIDS Treatment and Research)

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Darunavir (DRV) is a new protease inhibitor used to treat human immunodeficiency virus (HIV) type-1. The aim of this study was to validate the determination of plasma DRV concentrations using the HPLC method, a simple procedure for simultaneous determination of seven HIV protease inhibitors and efavirenz. The calibration curve was linear (range of 0.13 to 10.36 μg/ml). The average accuracy ranged from 100.7 to 105.6%. Both the interday and intraday coefficients of variation were less than 6.7%, which was similar to or much lower than previously reported values by the LC/MS/MS method. It is concluded that HPLC can be used to determine plasma DRV concentrations and routinely in the clinical setting; thus, this HPLC method enables further study of DRV pharmacokinetics in conventional hospital laboratories.

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