ABSTRACT

A new simple, accurate, rapid, precise and reproducible spectrophotometric method for the quantitative estimation Sofosbuvir in bulk form. The developed visible spectrophotometric method for the quantitative estimation of Sofosbuvir is based on measurement of absorption at maximum wavelength 260 nm using with acetonitrile: methanol (30:70) as a solvent. The stock solution of Sofosbuvir was prepared, and subsequent suitable dilution was prepared in diluent to obtained standard curve. The standard solution of Sofosbuvir shows absorption maxima at 260 nm. The drug obeyed beer lambert’s law in the concentration range of 5 - 25 ?g/ml with regression 0.9991 at 260 nm. The overall % recovery was found to be 99.63% which reflects that the method was free from the interference of the impurities and other excipients used in the bulk form. The low value of % RSD was indicative of accuracy and reproducibility of the method. The % RSD for inter-day and intra-day precision was found to be 0.5863 and 0.8896, respectively which is<2% hence proved that method is precise. The results of analysis have been validated as per International Conference on Harmonization (ICH) guidelines. The developed method can be adopted in routine analysis of Sofosbuvir in bulk form. Keywords: Sofosbuvir, UV Visible Spectrophotometry, Method development, Validation, ICH guidelines, Acetonitrile, methanol, Accuracy, Precision
Publication date: 01/05/2024

https://ijbpas.com/pdf/2024/May/MS_IJBPAS_2024_8033.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.5.8033