Economic and Green RP-HPLC Method for Simultaneous Determination of Sofosbuvir, Ledipasvir, Velpatasvir Antivirals and Beyond in Their Bulk Material and Co-Formulated Products
25 Pages Posted: 21 Sep 2022
Abstract
In the present era, pharmaceutical industry is floated with the development of novel antiviral medications either in single or co-formulated pills, to face well-known conditions (Hepatitis C, HIV, influenza, and herpes simplex) and the newly emerging infectious diseases (Ebola, swine flu and SARS-CoV-2). This growth of antiviral drug market is gaining the interest due to economic and therapeutic policies. Therefore, it is a real demand to validate analytical methods that monitor the entire standards related to their quality, safety and efficacy with maximum accuracy and maximum time and cost efficiency.HPLC offers a quick, automated, and highly accurate method to identify certain chemical components in a sample. Medical, forensic, bioavailability, environmental and manufacturing labs use the technique to quantify and separate the chemicals in a multicomponent sample. Consequently, an HPLC method is developed for quantitative analysis of a mixture containing five anti-viral agents namely, sofosbuvir, ledipasvir, velpatasvir, daclatasvir and valacyclovir. The method based on partitioning between reversed phase and methanol/water mobile phase with gradient elution at 1 mL/min flow rate and UV detection at 260 and 330 nm wavelengths. The greenness profile was assessed on Analytical Eco-scale and GAPI tools and found to be in agreement with the green analytical chemistry principles. The proposed method was validated experimentally and statistically and found to be a viable choice for single and multicomponent analysis in multi-tasks laboratory that consider the environmental impact and quality-cost balance.
Keywords: Green analysis, HPLC, Sofosbuvir, Ledipasvir, Velpatasvir, Daclatasvir and Valacyclovir
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