HPLC-UVを用いたソホスブビルの定量法の確立 Determination of sofosbuvir via a high-performance liquid chromatography method using ultraviolet detection
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Sofosbuvir (SOF) is a nucleotide analog drug that inhibits hepatitis C virus replication. In the present study, we aimed todevelop a simple, specific, sensitive, and precise method for the quantification of SOF in water-based and human plasmasamples by using a high-performance liquid chromatography method with ultraviolet detection (HPLC-UV). The analyte wasextracted from 0.25 mL water or human plasma samples with an acetonitrile-based solution and analyzed on a C18 reversedphasecolumn. Sorafenib was used as an internal standard (IS). The mobile phase was composed of ammonium acetatebuffer, and methanol and acetonitrile. The flow rate was 1.0 mL/min, and the UV wavelength was set at 265 nm. Theretention times of SOF and IS were 7.8 min and 9.1 min, respectively. The total run time for a single analysis was 15.0 min.The calibration curve was linear within the range 0.1-10.0 μg/mL. The limit of quantitation was 0.1 μg/mL. The recovery ofthe drug from human plasma samples was greater than 99 %. The intra- and inter-day precision of water-based and plasmasamples ranged from 1.41% to 10.06% and 0.21 to 6.53%, respectively. The intra- and inter-day accuracy of water-based andplasma samples ranged from 92.71 to 98.41% and 89.31 to 101.21%, respectively. The proposed method is very simple andallows acquiring a good recovery of the analytes. The developed HPLC-UV method may be applied to conductingpharmacokinetic studies in the determination of SOF.
国際医療福祉大学学会誌 23(1), 130-136, 2018