Abstract
Objective: The present study aimed to develop a stability-indicating reverse-phase high performance-liquid chromatography (RP-HPLC) method for the estimation of Sofosbuvir, Velpatasvir, and Voxilaprevir in tablet dosage form and validated in accordance with ICH guidelines. Methods: The optimized conditions for the developed RP-HPLC method are Agilent C18 (250 mm×4.6mm, 5μ) column maintained at 30ºC with a mobile phase consisting of Buffer(0.1%OPA) and Acetonitrile taken in the ratio 55:45%v/v on isocratic mode at flow rate 1.0ml/min. The sample was detected at 220 nm. Results: The retention time of Sofosbuvir, Velpatasvir, and Voxilaprevir was found to be 2.17, 2.731 and 3.55 min respectively. The developed method was validated for accuracy, precision, specificity, ruggedness, robustness and solution stability.
Highlights
The present study aimed to develop a stability-indicating reverse-phase high performance-liquid chromatography (RP-HPLC) method for the estimation of Sofosbuvir, Velpatasvir, and Voxilaprevir in tablet dosage form and validated in accordance with ICH guidelines
Objective: The present study aimed to develop a Sofosbuvir [2] (Fig 1) is a nucleotide prodrug and a stability-indicating reverse-phase high performance-liquid hepatitis C virus (HCV) NS5B polymerase inhibitor with chromatography (RP-HPLC) method for the estimation of potential HCV inhibiting activity
The net degradation was found to be within the limits, indicating that the drug is stable in stressed conditions
Summary
Objective: The present study aimed to develop a stability-indicating reverse-phase high performance-liquid chromatography (RP-HPLC) method for the estimation of Sofosbuvir, Velpatasvir, and Voxilaprevir in tablet dosage form and validated in accordance with ICH guidelines. Objective: The present study aimed to develop a Sofosbuvir [2] (Fig 1) is a nucleotide prodrug and a stability-indicating reverse-phase high performance-liquid hepatitis C virus (HCV) NS5B polymerase inhibitor with chromatography (RP-HPLC) method for the estimation of potential HCV inhibiting activity. Sofosbuvir, Velpatasvir, and Voxilaprevir in tablet dosage form drug in the treatment of Hepatitis C virus. It is chemically and validated in accordance with ICH guidelines
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