| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 1220963 | Journal of Pharmaceutical and Biomedical Analysis | 2016 | 7 Pages |
•The first HPLC–UV method was developed for the determination of simeprevir in human plasma.•The stability of simeprevir to heat treatment used for HCV inactivation was evaluated.•This method was applied to measurement of simeprevir in clinical samples.
A simple high-performance liquid chromatography method for the determination of the hepatitis C virus protease inhibitor simeprevir in human plasma was developed and validated. The method involved a rapid and simple solid-phase extraction of simeprevir using Oasis HLB 1cc cartridges, isocratic reversed-phase liquid chromatography on an XTerra RP18 (150 mm × 4.6 mm, 3.5 μm) column, and ultraviolet detection at 225 nm. The mobile phase consisted of phosphate buffer (pH 6, 52.5 mM) and acetonitrile (30:70, v/v). This assay proved to be sensitive (lower limit of quantification of 0.05 μg/mL), linear (correlation coefficients ≥0.99), specific (no interference with various potentially co-administrated drugs), reproducible (both intra-day and inter-day coefficients of variation ≤8.3%), and accurate (deviations ranged from −8.0 to 1.2% and from −3.3 to 6.0% for intra-day and inter-day analysis, respectively). The method was applied to therapeutic monitoring of patients undergoing simeprevir treatment for hepatitis C and proved to be robust and reliable. Thus, this method provides a simple, sensitive, precise and reproducible assay for dosing simeprevir that can be readily adaptable to routine use by clinical laboratories with standard equipment.
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