NEW ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF SOFOSBUVIR AND VELPATASVIR IN BULK AND PHARMACEUTICALDOSAGE FORMBYRP-UPLCMETHOD

Authors

  • Sandhya Rani.Baratam, Raghu Prasad Mailavaram,Rajendra Prasad Yejella,SurendraBabu lagu,Ramanamma Lalam, Jagadeesh panda Author

DOI:

https://doi.org/10.48047/

Keywords:

Sofosbuvir,Velpatasvir,Validation,BufferandICHGuidelines.

Abstract

A simple, specific and accurate reverse phase ultra-performance liquid chromatographic method was
developed for the simultaneousdetermination Sofosbuvir and Velpatasvirin pharmaceutical dosage form.
The column used was Kromosil C18(150mm x 4.6 mm, 5µm)inisocratic mode, with mobile phase
containing phosphate buffer andacetonitrile(75:25v/v). The flow rate was 1.0ml/ min and effluents
weremonitored at 260 nm. The retention times of Sofosbuvir and Velpatasvirwere found to be 2.404min
and 2.986 min, respectively.The linearityfor Sofosbuvir and Velpatasvirwere in the range of 35-210µg/ml
and 8-48 µg/ml respectively. The recoveries of Sofosbuvir andVelpatasvirwere found to be 99.64% and
99.25%, respectively. The proposed method was validated and successfully applied to the
estimationofSofosbuvirandVelpatasvirincombinedtabletdosageforms.

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Published

2021-04-21