Development of a simple HPLC-UV method for the determination of the hepatitis C virus inhibitor simeprevir in human plasma.

J Pharm Biomed Anal

Department of Molecular Medicine, University of Padua, Padua, Italy; Clinical Microbiology and Virology Unit, Padua University Hospital, Padua, Italy.

Published: March 2016

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.

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jpba.2016.01.019DOI Listing

Publication Analysis

Top Keywords

method determination
8
determination hepatitis
8
hepatitis virus
8
inhibitor simeprevir
8
simeprevir human
8
human plasma
8
liquid chromatography
8
intra-day inter-day
8
method
5
simeprevir
5

Similar Publications

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!