SIMULTANEOUS ESTIMATION OF VELPATASVIR AND SOFOSBUVIR IN BULK AND COMBINED TABLET DOSAGE FORM BY A SIMPLE VALIDATED STABILITY INDICATING RP-HPLC METHODAbstract
A Simple, sensitive, specific and stability indicating RP-HPLC method was developed for the simultaneous estimation of velpatasvir and sofosbuvir in bulk and tablet dosage form. Effective separation attained by injecting 10 μL of the standard solution containing velpatasvir and sofosbuvir into Xbrdige Phenyl (250 × 4.6 mm, 5 µ, 100 A0) column, with a mobile phase containing methanol, buffer (0.1% formic acid in water) and acetonitrile in 40:30:30 v/v ratio, at a flow rate of 1ml/min. The eluted analytes were effectively responded qualitatively and quantitatively at 273 nm wavelength. The drugs were experienced in stress conditions such as oxidative, acid, base, photolytic, and thermal degradation. The retention times of sofosbuvir and velpatasvir were observed at 3.4 and 5.1 min, respectively. The method has a good linear response in the concentration range of 10-30 µg/ml and 40-120 µg/ml for velpatasvir and sofosbuvir respectively. LOD and LOQ were calculated as 1 µg/ml and 4 µg/ml for velpatasvir, 4 µg/ml, and 13 µg/ml for sofosbuvir. All the obtained validation parameters have been satisfied the acceptance limits of ICH guidelines. The degradants peaks were resolved significantly from sofosbuvir and velpatasvir peaks. The developed method was sensitive, specific, accurate, and stability-indicating. Thus, this method can be useful in the quality control department to estimate velpatasvir and sofosbuvir perfectly.
R. Godela * and G. Sowjanya
GITAM Institute of Pharmacy, GITAM Deemed to be University, Visakhapatnam, Andhra Pradesh, India.
19 November 2019
25 February 2020
13 March 2020
01 November 2020