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ISSN 2063-5346
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STRESS DEGRADATION STUDIES AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION OF ANTI-VIRAL DRUGS SOFOSBUVIR AND LEDIPASVIR IN BULK AND PHARMACEUTICAL DOSAGEFORMS BY RP-HPLC

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K.KALYANI1*,K. LAKSHMI2, M. SRIKANTH KUMAR3, K. NAGALAKSHMI4, T.SURESH5
» doi: 10.31838/ecb/2023.12.3.124

Abstract

Sofosbuvir and Ledipasvir are antiviral drugswidely used in the treatment of hepatitis C virus infections. The same combinations of drugs also used in the treatment of patients with mild to moderate COVID-19. The aim of the studies was to evaluate the stability of the drugs under stress.The drugs were subjected to stress degradation studies as per the conditions prescribed in ICH Q1 (R2) guideline. Sofosbuvir and Ledipasvir are subjected under stress conditions acid, alkaline,neutral,oxidative, thermal and photolytic conditions. The drugs were found to be highest stability under oxidative, thermal and photolytic conditions. The method also validated according to the ICH guidelines, for the simultaneous determination of Sofosbuvir and Ledipasvir in pure and market formulations. Separation was carried out using column Hypersil BDS (250mm x4.6 mm,5μm particle size) in isocratic mode using mobile phase composition was 40:60 phosphate buffer: Acetonitrile and pH was adjusted to 3 with sodium hydroxide and UV detection at 265 nm. The compounds were eluted at a flow rate of 1.0mL min−1.The average retention times for Sofosbuvir and Ledipasvir were 2.511and 3.127 respectively. The method was linear over the concentration of 100-600 μg/ml and 22.5- 135 μg/ml forSofosbuvir and Ledipasvir. Correlation coefficient was found to be 0.9992 &0.9993 for Sofosbuvir and Ledipasvir respectively.

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