Abstract
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD AND SIMULTANEOUS ESTIMATION OF SOFOSBUVIR AND VELPATASVIR IN BULK AND DOSAGE FORM

Sagar E. Tambe*, Shivani S. Yendhe and Sachin V. Datkhile

ABSTRACT

Objective: To develop UV-Visible spectrophotometric method for estimation of combination of Sofosbuvir and Velpatasvir. To develop analytical method for quantitation of combination of Sofosbuvir and Velpatasvir by RP-HPLC and Validate this method as per ICH guidelines.[1,2,3] Method: New Analytical method was developed for the estimation of Velpatasvir and Sofosbuvir by chromatographic separation. It was achieved on Grace C18 column (250mm* 4.6 ID, Particle size-5 micron) by employing a mobile phase comprised of Methanol:Water (80:20). The flow rate was 0.8ml/ minute and ultra violet detector was set at 266nm. The average retention time for Velpatasvir and Sofosbuvir was found to be 7.52 min and 4.72 min. Results: The method was optimized by using methanol and water (80:20) with flow rate 0.8 ml/min. The % assay was found to be 99.85%for sofosbuvir and 99.76% for Velpatasvir. The Robustness parameter i.e. standard deviation was found to be less than 2 for Sofosbuvir and Velpatasvir both. Conclusion: This novel method was found suitable for the routine quantitative analysis of Velpatasvir and Sofosbuvir in bulk and pharmaceutical dosage form. The method was accurate, precise, linear, reproducible, robust, and sensitive.

Keywords: Sofosbuvir, Velpatasvir, Grace C18 column, Antiviral, Nucleotide Polymerase Inhibitor.


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