DEVELOPMENT AND VALIDATION OF STABILITY INDICATING UV SPECTROSCOPIC METHOD FOR ESTIMATION OF SOFOSBUVIR

Author(s): Santosh V. Gandhi* and Pooja R. Alli

Abstract: A stability-indicating UV Spectrophotometric method has been developed for analysis of the drug in the presence of the degradation products and is validated as per ICH Q2 R1 guidelines. Sofosbuvir in water shows maximum absorbance at 260.5 nm. The data of linear regression analysis indicated a good linear relationship over the range of 10-100 μg/ml concentrations with a correlation coefficient (R2) of 0.9984. The LOD and LOQ were found to be 0.269 μg/ml and 0.814 μg/ml respectively. A recovery of Sofosbuvir in tablet formulation was observed in the range of 99.524-101.208 %. Percentage assay of Sofosbuvir tablets was found to be in the range of 99.812-101.740 %. Sofosbuvir was subjected to different stress testing conditions. Degradation of Sofosbuvir was mainly found in alkaline condition. The developed method was found to be simple, accurate and precise for analysis of Sofosbuvir and can be adopted for routine analysis of drug in bulk and pharmaceutical dosage form.

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