RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF LEDIPASVIR AND SOFOSBUVIR IN FIXED DOSAGE FORMAbstract
Ledipasvir and Sofosbuvir Combination have been approved for the treatment of Chronic Hepatitis C Viral Infection. Here an accurate, valid, elementary, and error-free reverse-phase liquid chromatography strategy was developed for the quantitation of Ledipasvir and Sofosbuvir in its bulk form as well as in fixed dosage form. Effective chromatographic separation of Ledipasvir and Sofosbuvir was achieved by using Kromasil C-18 (250 × 4.6 mm, 5 µm) column using Phosphate buffer (pH 3.5) and Methanol in the proportion of 45:55 v/v. The Mobile phase was siphoned at a flow rate of 1.0 mL min-1 with a column temperature of 35 ºC, and detection wavelength was carried out at 259 nm. The retention time was found to be 3.294 min for Sofosbuvir and 4.630 min for Ledipasvir. The dimensionality of Sofosbuvir and Ledipasvir was in linear range with a parametric static of 0.999 and 0.999. Method Validation was carried out in terms of Specificity, Linearity, Precision, Accuracy, LOD, LOQ as per ICH Guidelines. Results obtained from the validation studies show that the developed method can be useful in the quality control analysis of bulk and pharmaceutical formulations of Ledipasvir and Sofosbuvir.
V. P. Kumar, N. Harikrishnan * and G. Subramanian
Faculty of Pharmacy, Dr. M.G.R. Educational and Research Institute, Velappanchavadi, Chennai, Tamil Nadu, India.
10 July 2020
09 December 2020
15 May 2021
01 July 2021