Green RP-HPLC method for simultaneous determination of sofosbuvir, ledipasvir, velpatasvir antivirals and beyond in their bulk material and co-formulated products

Abstract

In the present era, pharmaceutical industry is floated with the development of novel antiviral medications either in single or co-formulated pills. 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 considering 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 (SF), ledipasvir (LD), velpatasvir (VL), daclatasvir (DC), and valacyclovir (VC) 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 along linear concentration ranges 5.00–80.00, 2.00–50.00, 5.00–50.00, 2.00–80.00 and 5.00–45.00 µg/ mL for SF, LD, VL, DC and VC, respectively.The greenness profile was assessed using 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 with precision RSD% <2.00 % and accuracy ranging from 99.79 to 100.90 %.