الفهرس 
Title : Liquid chromatography methods for determination of CO-treatment drug for hepatitis C
AbstractOnly 14 pages are availabe for public view
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Abstract
The present study involves development of a new and unique high-performance liquid chromatography (HPLC) method using fluorescence detection for the determination of simeprevir (SIM) in human plasma and pharmaceutical dosage form. For human plasma application, the developed method is based on protein precipitation using acetonitrile (ACN) followed by cleaning the samples for HPLC injection. A 0.025 mol/L dipotassium hydrogen orthophosphate (pH7.0)/ACN (50/50; v/v), was used as mobile phase and C18 reversed phase column as the stationary phase. The chromatographic conditions were optimized, and the concentration of SIM was determined by using fluorescence detector. Cyclobenzaprine (CYC) was used as an internal standard (IS). This method showed linearity in the range of 10 to 3000 ng/mL. The recovery of SIM was 84.98-102.06%. Intra-day and inter-day accuracies were 92.30-107.80%, with relative standard deviation (RSD) 1.65-8.02%.The present method was successfully applied to a pharmacokinetic study where SIM was administered as a single dosage of 150 mg SIM/capsule (Olysio®) to healthy individuals. For Pharmaceutical dosage form, rapid, simple and selective HPLC method was developed and validated for determination of simeprevir (SIM) in pharmaceutical capsules dosage form