Volume 28‎ > ‎

Rapid High-Performance Liquid Chromatographic Method for Determination of Simeprevir In Pharmaceutical Dosage Form

Ahmed A. Youssef, Yousry M Issa & Kareem M. Nabil

1Chemistry Department, Faculty of Science, Cairo University, Giza, Egypt

2Pharmagene Specialized Analytical Services, Giza, Egypt


Summary: Rapid, simple and selective HPLC method was developed and validated for determination of simeprevir (SIM) in pharmaceutical capsules dosage form. Chromatographic separation was achieved by using RP-C18 column as stationary phase and acetonitrile (ACN): potassium phosphate, 70:30 (v/v), as mobile phase in a flow rate 1.5 mL/min. The effluent was detected using fluorescence detector. The method showed a linear range 10-2000µg/mL with excellent correlation coefficient> 0.999. Parameters of validation were studied to ensure obtaining accurate and precise data. The developed method was applied successfully to the analysis and determination of SIM in OLYSIO® (150 mg/capsule) as pharmaceutical dosage form.