Environmental impact of the reported chromatographic methods for the determination of the first FDA-Approved therapy for COVID-19 Patients, Remdesivir: A comparative study

Amal B Ahmed; Mohammed Gamal; Ibrahim A Naguib; Hazim M Ali; Fatma F Abdallah

doi:10.1016/j.microc.2022.107242

Environmental impact of the reported chromatographic methods for the determination of the first FDA-Approved therapy for COVID-19 Patients, Remdesivir: A comparative study

Microchem J. 2022 May:176:107242. doi: 10.1016/j.microc.2022.107242. Epub 2022 Jan 30.

Authors

Amal B Ahmed¹, Mohammed Gamal², Ibrahim A Naguib³, Hazim M Ali⁴, Fatma F Abdallah²

Affiliations

¹ Pharmaceutical Chemistry Department, Faculty of Pharmacy, Nahda University, 62514, Beni-Suef, Egypt.
² Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmad Hegazy St., Beni-Suef 62514, Egypt.
³ Department of Pharmaceutical Chemistry, College of Pharmacy, Taif University, P.O. Box 11099, Taif 21944, Saudi Arabia.
⁴ Department of Chemistry, College of Science, Jouf University, P.O. Box 2014, Sakaka, Aljouf, Saudi Arabia.

Abstract

Remdesivir (REM) is considered the first therapeutic option approved by US Food and Drug Administration (FDA) for clinical care in case of hospitalized patients suffering in COVID-19 epidemic. In the presented multilateral comparative search, four eco friendlessness approaches -National Environmental Methods Index (NEMI), Eco-Scale Assessment (ESA), Green Analytical Procedure Index (GAPI), and Analytical Greenness metric (AGREE) are tested to assess 16 analytical chromatographic procedures reported for the analysis of the commonly used antiviral drug; Remdesivir (REM). The values of testing more than one approach when estimating the eco-friendly characters for analytical methods are illustrated in this study. On the light of the outcomes, ESA and AGREE approaches are recommended as they are easily applied and digitally presented. Furthermore, GAPI is also a reliable tool in terms of comprehensiveness for the whole analytical procedures, from sampling till the final assessment. NEMI is the easiest and fastest greenness evaluation tool; however, the information it provides is particularly of limited scope and sometimes inaccurate. To ensure greenness of chromatographic analytical methods, there must be clear planning beforehand, to reduce chemical hazards sent to environment. Additionally, it is highly recommended in method validation protocols to consider the greenness of a given analytical procedure before releasing to routine use. The LC-MS/MS analysis for the active metabolite of REM (Nuc) reported by Avataneo et al. and Du et al. proved to be the best bio-analytical methods regarding the environmental aspects depending on the GAPI and AGREE tools. However, the HPLC method for REM analysis in intravenous solution reported by Jitta et al. proved to be the greenest analytical method for determination of REM in the pharmaceutical dosage forms according to the ESA, GAPI, and AGREE tools.

Keywords: Analytical Greenness metrics; Eco-Scale Assessment; Green Analytical Procedure Index; National Environmental Methods Index; Remdesivir.