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Original Article

J App Pharm Sci. 2017; 7(2): 114-119


Validated Ultraviolet-Spectrometric Method for Determination of Sofosbuvir in Tablets Formulation

Mohamed A. El Hamd; Ramadan Ali; Adel A. Marzouk; Osama H. Abdelmageed.

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.

Key words: Ultraviolet spectrophotometric determination. Sofosbuvir tablets formulation. Quality control analysis



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