DEVELOPMENT AND VALIDATION OF STABILITY INDICATING UPLC METHOD FOR SIMULTANEOUS ESTIMATION OF SOFOSBUVIR AND VELPATASVIR IN TABLET DOSAGE FORMAbstract
The objective of the method was to develop a simple, rapid, sensitive, precise, accurate and validated Ultra Performance Liquid Chromatographic (UPLC) method for the simultaneous estimation of Sofosbuvir and Velpatasvir in tablet dosage form. Chromatographic separation was achieved on an acquity UPLC HSS C18, 2.1 × 100 mm, 1.8µ column with a mobile phase composed of orthophosphoric acid buffer and acetonitrile in the ratio of 45:55 at a flow rate of 0.2 ml/min and 1 μl injection volume. The effluents were detected at a wavelength of 250 nm using TUV detector. The retention times of Sofosbuvir and Velpatasvir were found to be 1.425 and 1.767 min respectively. The method was validated with respect to specificity, accuracy, linearity, precision, robustness. The correlation coefficient for Sofosbuvir and Velpatasvir were found to be 0.9992 and 0.9995 respectively. Recovery of Sofosbuvir and Velpatasvir in formulation was found to be 99.48% and 99.6% respectively. Due to simplicity, high precision and rapidness the method can be successfully applied for simultaneous estimation of Sofosbuvir and Velpatasvir in combined dosage form.
A. G. Susmita * and G. Rajitha
Institute of Pharmaceutical Technology, Sri Padmavati Mahila Visvavidyalayam (Women's University), Tirupati, Andhra Pradesh, India.
14 February, 2018
11 September, 2018
16 October, 2018
01 November, 2018