• R Swetha sri
• Dr.Mitta Chaitanya
• Dr Kalepu Swathi
• Koduru Swathi

A simple, rapid, precise, accurate and sensitive reverse phase liquid chromatographic method has been developed for the determination of Sofosbuvir in API and pharmaceutical dosage form dosage form. The chromatographic method was standardized using Develosil ODS HG-5 RP C18, 5µm, 15cm x 4.6mm i.d. column with UV detection at 264 nm and Methanol : Acetonitrile (55:45) ratio at a flow rate of 1.0 ml/ min. The proposed method was successfully applied to the determination of Sofosbuvir in bulk and pharmaceutical dosage form. The method was linear over the range of 0 g/ml to 16 g/ml. The recovery was in the range of 98% to 102% and limit of detection was found to be 0.09 µg/ml and quantification was found to be 0.27 µg/ml. Different analytical performance parameters such as precision, accuracy, limit of detection, limit of quantification and robustness were determined according to International Conference on Harmonization (ICH) guidelines.

RP-HPLC, Sofosbuvir, Method development and validation, ICH Guidelines

"VALIDATION AND FORCED DEGRADATION STUDIES FOR THE QUANTITATIVE ESTIMATION OF SOFOSBUVIR IN API AND PHARMACEUTICAL DOSAGE FORM", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.6, Issue 4, page no.647-658, April-2019, Available :http://www.jetir.org/papers/JETIR1904899.pdf

"VALIDATION AND FORCED DEGRADATION STUDIES FOR THE QUANTITATIVE ESTIMATION OF SOFOSBUVIR IN API AND PHARMACEUTICAL DOSAGE FORM", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.6, Issue 4, page no. pp647-658, April-2019, Available at : http://www.jetir.org/papers/JETIR1904899.pdf