Abstract
A simple, direct and rapid ultraviolet spectrometric method was developed and validated for determination of sofosbuvir (SOF) in its tablets formulation. SOF was dissolved in methanol and measured in ultraviolet region at λmax of 260 nm. The linearity of the calibration curve was over the concentration range of 5 - 100 μg/mL with a correlation coefficient of 0.999. The sensitivity was checked as the limit of detection and limit of quantification which were found to be 1.6 and 4.8 µg/mL respectively. The percentage recoveries of SOF, after extraction from its tablets, were ranged from 98.23 ± 1.04% 99.38 ± 0.40% with a relative standard division less than 2.0% indicating acceptable accuracy and precision of the developed method. Further studies of the accuracy and precision of the proposed method were performed using standard addition method; the mean quantitative recovery of such studies were found to be in the range 97.99 ± 0.32 to 99.69 ± 0.15 with RSD ≤ 2.0%. These levels of accuracy and precision obtained indicate suitability of the developed method for the quality control analysis of the SOF in its tablets formulation.
Highlights
Sofosbuvir, an isopropyl (2S)-2-[[[ (2R,3R,4R,5R)-5(2,4-dioxopyrimidin-1-yl) -4-fluoro-3- hydroxy-4-methyltetrahydrofuran-2-yl] methoxy-phenoxy-phosphoryl]amino] propanoate (SOF, Fig. 1) is a recent novel nucleotide derivative was described as a typical inhibitor of hepatitis C virus (HCV) (Summers et al, 2014) in Egypt
Spectrophotometric standardization To select the most appropriate diluting solvent; a working solutions at the quality control samples (QCs) concentration levels were diluted with acetic anhydride, acetone, acetonitrile, amyl alcohol, benzene, carbon tetra-chloride, dichloroethane, dichloromethane, dimethyl formamide, dimethyl sulphoxide, 1,4-dioxane, ethanol, ethyl acetate, hexane, isopropanol, methanol, triethylamine, water, 1N hydrochloric acid (HCl) and 1N NaOH (Table 1)
The RE% was observed within 0.66 and 2.0% for intra- and inter-days respectively. These results indicate that the present method was accurate, reliable and has repeatability for the quantitative analysis of SOF in tablets, Table 3
Summary
Sofosbuvir, an isopropyl (2S)-2-[[[ (2R,3R,4R,5R)-5(2,4-dioxopyrimidin-1-yl) -4-fluoro-3- hydroxy-4-methyltetrahydrofuran-2-yl] methoxy-phenoxy-phosphoryl]amino] propanoate (SOF, Fig. 1) is a recent novel nucleotide derivative was described as a typical inhibitor of hepatitis C virus (HCV) (Summers et al, 2014) in Egypt. The discovery of this drug was considered as a promising new one for treatment of patients suffer from HCV. It is prodrug of 2'-deoxy-2'-fluoro-2'-Cmethyluridine monophosphate that is phosphorylated intracellularly to the active triphosphate form, which acts as an inhibitor of HCV non-structural 5B ribonucleic acid polymerase (Imran et al, 2013).
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