A simple and sensitive chromatographic method has been developed for the quantitative analysis
of an antiviral agent, daclatasvir (DCV), that commonly prescribed for the treatment of hepatitis
C viral (HCV) infection. The method was applied to detect DCV in human plasma and real blood
samples collected from patients diagnosed with HCV and treated with DCV. The analysis strategy
was based on recording the native fluorescence of DCV in plasma, after pre-column treatment to
precipitate the plasma proteins using a readily applicable protocol. Chromatographic
conductions, factors influencing the fluorescence and stability studies were also investigated.
Furthermore, the method was validated according to the International Conference on
Harmonization (ICH) guidelines and could be used to detect DCV in plasma over a linear range of
1.0 to 4000 ng/mL, with an acceptable sensitivity as the limit of detection (LOD) was 0.025 ng/mL.
In addition, the study was extended to evaluate pharmacokinetic interaction between DCV and
a co-prescribed antidepressant drug, fluoxetine (FLX) in real blood samples, collected from
volunteering patients who were diagnosed with HCV and treated with DCV alone or combined
with FLX. The results showed a significant influence of FLX on the pharmacokinetic profile of DCV.
The findings observed in this study could be used by clinical pharmacists adjust the DCV dose,
when combined with FLX, during the HCV treatment.