Sofosbuvir (SOF) and daclatasvir (DCS) are novel, recently developed direct acting antiviral agents characterized by potent anti-hepatitis C virus action. A fast and efficient HPLC-UV method was developed, validated and applied for simultaneous determination of SOF and DCS in pharmaceutical formulations and biological fluids based on coupling liquid-liquid extraction with ultrasound and dual wavelength detection at λmax; 260 and 313 nm for SOF and DCS, respectively. This approach provided simple, sensitive, specific and cost-effective determination of the SOF-DCS mixture with good recoveries of the analytes from plasma. Analytes were separated within 7 min on C18 analytical column with acetonitrile–10 mM acetate buffer of pH 5.0 at a flow rate of 1.0 mL min−1. The linear ranges were 1–20 μg mL−1 for SOF and 0.6–6 μg mL−1 for DCS with correlation coefficients ≥0.9995. The detection limits in spiked rabbit plasma were 0.20 and 0.19 μg mL−1 for SOF and DCS, respectively. The method was validated according to ICH and US-FDA guidelines. Finally, the method was successfully applied for simultaneous pharmacokinetic studies of SOF and DCS in rabbits using rofecoxib as internal standard.
Research Department
Research Journal
Journal of Pharmaceutical and Biomedical Analysis
Research Publisher
Elsevier
Research Rank
1
Research Vol
Vol. 158
Research Website
https://doi.org/10.1016/j.jpba.2018.05.028
Research Year
2018
Research Member
Research Abstract