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. |
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