Sustainability assessment of PDE-5 inhibitor analysis: A comparative study using AGREE, AGREEPrep, Complex GAPI, and BAGI

Abstract

Phosphodiesterase type 5 (PDE5) inhibitors are widely used to treat erectile dysfunction and pulmonary hypertension. However, their safety has come under scrutiny due to frequent recalls by the U.S. Food and Drug Administration (FDA). These recalls often result from impurities, mislabelling, or unapproved ingredients, posing health risks to patients. This study aims to develop sustainable methods for the early detection of at-risk PDE5 inhibitors through green analytical chemistry concepts. A systematic review of literature from 2020 to 2024 identified over 2000 publications on Green Analytical Chemistry, including 121 focused on PDE5 inhibitors, from which 37 key analytical references were selected for detailed evaluation, consist of methods such as UV spectrophotometry, HPLC, and mass spectrometry. The research uses tools like AGREE, AGREEprep, GAPI, and BAGI to find eco-friendly methods for analysing PDE5 inhibitors. All published work on PDE5 inhibitor drugs evaluated using green analytical tools, and greenness scores were calculated to determine sustainable methods for quality control (QC) and to assess quality during manufacturing and post-market surveillance. The findings will support pharmacovigilance for manufacturers, regulators, providers, and consumers. The integration of green chemistry tools will also promote environmentally friendly practices, reducing the ecological footprint of pharmaceutical production. Overall, this research will support the development of safer, more sustainable medications, fostering greater trust among consumers and stakeholders in the healthcare industry.