Degradation Study Of Sofosbuvir In Bulk Drug And Tablet Dosage Form By RP-High Performance Liquid Chromatography
DOI:
https://doi.org/10.61841/3tq7qp04Keywords:
Sofosbuvir, RP-HPLC, Method Development, Method Validation, StabilityAbstract
Sofosbuvir was subjected to forced degradation conditions, and the formed degradation products were well separated and resolved from the drug and excipients on a SunFire C18 column (250 × 4.6 mm, 5 μ) using a blend of acetonitrile and water (70:30 v/v) at pH 7.0 in isocratic mode at a flow rate of 0.8 mL/min at an ambient temperature of 28 °C with the detection wavelength at 260nm. The retention time of Sofosbuvir was found to be 3.22 min. The linearity was performed in the concentration range of 20-100 ppm with a correlation factor of 0.999 for Sofosbuvir. The percentage purity of the Sofosbuvir tablet was found to be 99.98%. The drug was found to degrade under acid, alkali, and oxidative conditions but was found to be stable under dry heat and photolytic conditions.
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