Simultaneous estimation of ledipasvir and sofosbuvir in bulk and its dosage forms by stability indicating RP-HPLC method

Abstract

The fixed-dose ledipasvir-sofosbuvir combination offers an effective and well-tolerated pill for the treatment of chronic hepatitis C infection. Only a few analytical works were carried out to estimate the Ledipasvir and Sofosbuvir drug combination in the various dosage forms. This work aimed to simplify the estimation process using RP-HPLC methodology. The method was developed on a reversed phase Agilent C18 (4.6 x 150 mm, 5 µm) column. The isocratic elution process was performed using a mobile phase ratio of Methanol (70% v/v): Water (30 % v/v) with 0.6 ml/min flow rate. Elute was scanned using the PDA detector at the wavelength of 235 nm. The results of the elution process showed that the Ledipasvir and Sofosbuvir elute the peak at a concentration of 9 μg/ml and 40 μg/ml with retention times of 7.745 min and 2.345 min respectively. The percentage purity of Ledipasvir and Sofosbuvir was found to be 99.40 % w/v and 98.20  % w/v. The proposed method was found to be a high degree of precision and reproducibility. The percentage recovery was found to be 99.92 % for Ledipasvir and 99.82 % for Sofosbuvir. The LOD and LOQ were measured, and the results were within limits. The developed validation method can be applied for degradation evaluation of Ledipasvir and Sofosbuvir for the various dosage forms.