Ecofriendly bioanalytical validated RP-HPLC method for simultaneous determination of COVID-19 co-prescribed drugs employing quality by design and green chemistry

Document Type

Article

Publication Date

2024

Abstract

High Performance Liquid Chromatography Co-prescribed drugs Human plasma Analytical quality by design Greenness assessment

1. Introduction

COVID-19 is a global pandemic disease that emerged in Wuhan province in late December 2019. The disease posed a major threat to the health of the world. It is caused by infection with SARS-CoV-2, which was isolated from patients exposed to seafood markets in Wuhan city [1]. Common symptoms of the virus include fever, cough, myalgia, and fatigue; less common symptoms include headaches, hemoptysis, and diarrhea [2]. Moreover, the disease may lead to pneumonia and respi- ratory failure due to the destruction of alveolar and bronchial epithelial cells or the massive generation of proinflammatory cytokines [3]. Leu- copenia, leukocytosis, lymphopenia, and high levels of alanine amino- transferase and aspartate aminotransferase are the most frequent

Molnupiravir, dexamethasone, ertapenem, and remdesivir are among the most frequently co-prescribed drugs used for COVID-19 virus treatment. For the first time, a simple isocratic reversed phase-high performance liquid chromatographic (RP-HPLC) method employing a photodiode array detector has been developed and validated for their simultaneous determination in spiked human plasma using rivaroxaban as an internal standard by the aid of quality by design and in accordance with the criteria of green chemistry. The separation was carried out utilizing a BDS Hypersil ® C18 column (300 × 4.6 mm), 5 μm particle size as the stationary phase using mobile phase consisted of methanol: acidified water; adjusted at pH 4.0 with 0.1 M orthophosphoric acid; with ratio (70:30, v:v) delivered at flow rate 0.6 mL/min, temperature adjusted at 20 ◦C, photodiode array detector maintained at 240 nm. The method was validated according to bioanalytical FDA guidelines with respect to linearity, accuracy, precision, selectivity, recovery, and stability. The method was found to be linear in the range of 4.00–120.00 μg/mL for molnupiravir, 10.00–140.00 μg/mL for dexamethasone, 10.00–160.00 μg/mL for ertapenem and 4.00–120.00 μg/mL for remdesivir. It is worth mentioning that the previously mentioned ranges covered the Cmax of the drugs. Finally, the green analytical score has been evaluated, and it was found to be an excellent green analytical method based on analytical eco-scale system penalty points. Moreover, it was assessed by analytical GREEnness metric approach and green analytical procedure index tool.

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