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

See all articles by Heba Moustafa

Heba Moustafa

Cairo University

Ahmed Saad

Egypt-Japan University of Science and Technology

Amani Morsi

Egyptian Drug Authority

Heba Essam

affiliation not provided to SSRN

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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Suggested Citation

Moustafa, Heba and Saad, Ahmed and Morsi, Amani and Essam, Heba, Economic and Green RP-HPLC Method for Simultaneous Determination of Sofosbuvir, Ledipasvir, Velpatasvir Antivirals and Beyond in Their Bulk Material and Co-Formulated Products. Available at SSRN: https://ssrn.com/abstract=4217382 or http://dx.doi.org/10.2139/ssrn.4217382

Heba Moustafa (Contact Author)

Cairo University ( email )

Ahmed Saad

Egypt-Japan University of Science and Technology ( email )

Egypt

Amani Morsi

Egyptian Drug Authority ( email )

Heba Essam

affiliation not provided to SSRN ( email )

No Address Available

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