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.
A plain sailing, unambiguous, speedy and error-free methodology was progressed for the quantifiable concurrent estimation of Pibrentasvir and Glecaprevir in conglomerated pharmaceutical dosage form. The contrivance was based on Chromatographic separation of both the drugs in reverse phase mode using C18 (250 X 4.6 mm), 5μ by utilizing phosphate buffer (pH 4.0) and Methyl alcohol in the ratio of 30:70 v/v was allowed to flow through column at a rate of 1.0 ml/min, and the detection wavelength was set at 251 nm. The time of retention was found to be 2.205 min for Glecaprevir and 4.996 min for Pibrentasvir. The dimensionality of Glecaprevir and Pibrentasvir was in linear range with a parametric statistic of 0.999 and 0.999. The acceptance criteria of precision was RSD should be not more than 2.0%, and the method showed precision 0.6 and 0.5 for Glecaprevir and Pibrentasvir, which shows that the method was precise. % Assay was found as 100.83 and 100.23, which show that the method was useful for routine analysis. The total recovery was founded to be100.40% and 100.25% for Glecaprevir and Pibrentasvir. LOD and LOQ for Glecaprevirwas found as 2.98 and 10.00 and LOD and LOQ for Pibrentasvir was found as 3.00 and 9.98. The methodology was assessed by various validation parameters in accordance with ICH Guidelines which indicates the method can be employed for routine quality control analysis.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.