METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF SOFOSBUVIR AND VELPATASVIR BY UV-VISIBLE SPECTROPHOTOMETRYAbstract
A simple, linear, precise, and economical UV spectro-photometric method has been developed for the simultaneous estimation of sofosbuvir and velpatasvir in the bulk and pharmaceutical dosage form. The standard stock solutions were prepared by using methanol as solvent. Estimation of sofosbuvir and velpatasvir was conducted by using a simultaneous equation method based on the measurement of Maximum absorbance at two wavelengths. The maximum absorbance was found at 261 nm for sofosbuvir and velpatasvir at 303 nm, respectively. The linearity was found in the concentration range of (5.0 μg/mL- 30.0 μg/mL) for sofosbuvir and (2.5 μg/mL-20.0 μg/mL) for velpatasvir with correlation coefficient of 0.996 for sofosbuvir and 0.994 for velpatasvir, respectively. Regression equation for sofosbuvir and velpatasvir were y = 0.0198x – 0.0061, y = 0.0225x + 0.029. The % accuracy was within the range of 98.04- 101.70%, and precision (%RSD) was found to be < 2. The developed method was validated according to ICH guidelines and successfully applied for the assay of marketing formulations.
P. Srawanthi *, D. Sireesha, G. Kiran, M. A. Haque and V. Bakshi
School of Pharmacy, Anurag Group of Institutions, Hyderabad, Telangana, India.
23 July 2020
15 December 2020
14 June 2021
01 July 2021