RP-HPLC Method Development, Validation, and Drug Repurposing of Sofosbuvir Pharmaceutical Dosage Form: A
Ghulam Rasool Mangrio1, Apichit Maneengam2, Zunera Khalid3
1Dr. M. A Kazi Institute of Chemistry, University of Sindh Jamshoro, 76090, Pakistan.
A new RP-HPLC method accurately quantifies Sofosbuvir (SOF) in pharmaceuticals. Sofosbuvir also shows potential for repurposing against SARS-CoV-2 by binding to its nsp12 protein.
Area of Science:
- Analytical Chemistry
- Pharmacology
- Computational Biology
Background:
- Sofosbuvir (SOF) is a crucial antiviral medication.
- Accurate quantification of SOF in pharmaceutical formulations is essential for quality control.
- Exploring novel therapeutic applications for existing drugs, like SOF, is vital.
Purpose of the Study:
- To develop and validate a sensitive RP-HPLC method for Sofosbuvir quantification.
- To investigate the potential of Sofosbuvir as a repurposed drug against SARS-CoV-2.
Main Methods:
- RP-HPLC method development using an Agilent 1260 system with a Phenomenex Luna C-18 column.
- Method validation including linearity, precision, accuracy, specificity, and selectivity.
- Molecular docking and Molecular Dynamics simulations to assess SOF interaction with SARS-CoV-2 nsp12.
Main Results:
- A highly sensitive and reproducible RP-HPLC method with a detection limit of 0.001 mg/mL was established.
- The method demonstrated excellent linearity (R²=0.99), recovery (98-99%), and assay (99%) for SOF.
- Molecular docking revealed strong binding affinity of SOF to the active site of SARS-CoV-2 nsp12, with stable interactions observed in simulations.
Conclusions:
- The developed RP-HPLC method is suitable for accurate Sofosbuvir determination in pharmaceutical dosage forms.
- Sofosbuvir shows promise as a repurposed therapeutic agent for COVID-19 treatment.
- Further in vivo studies and clinical trials are warranted to confirm SOF's efficacy against SARS-CoV-2.
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