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Abstract

DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF SOFOSBUVIR IN BULK FORM BY ABSORBANCE MAXIMA METHOD

R. M. Nemade*, M. N. Dole and Dr. S. D. Sawant

ABSTRACT

The present work was to develop simple UV spectrophotometric method in bulk form and validate as per ICH guidelines. Absorbance maxima method in which λmax was found to be 261 nm. Linearity was observed in the concentration range 5-40 μg/ml (r2=0.999) for the method. The % assay for the laboratory mixture for absorption maxima method was found to be 99.53% respectively. The method was validated with respect to linearity, precision and accuracy studies. Recovery studies for absorption maxima method was found to be 100.53%, 100.5% and 100.28% respectively. The developed method was validated for linearity, precision, accuracy, LOD and LOQ as per ICH guidelines. The present method was found to be simple, linear, precise, accurate and sensitive and can be used for routine quality control analysis for the estimation of Sofosbuvir in bulk form.

Keywords: Sofosbuvir (SFS), Absorbance maxima method and ICH guidelines.


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