A novel electrochemical sensor for the analysis of vibegron as a newly approved FDA drug: a rational computational design and cleaning validation application

Abstract

A novel analytical tool was developed for the assay of the recently approved β3-adrenergic receptor agonist vibegron. This tool was also utilized in a cleaning validation process, in which the selection of a selective, sensitive, easy-to-use, and portable technique is preferred. For this purpose, a potentiometric solid-contact ion-selective electrode was fabricated for vibegron detection. Firstly, a smart and effortless approach was adopted for choosing the optimum electrochemical ionophore in the potentiometric sensor. The theoretical assumptions were practically verified by studying the selectivity of various electrodes with different studied ionophores towards vibegron and another structurally related molecule, mirabegron. The selected electrode showed a linear response over a concentration range of 1.0 × 10⁻⁷–1.0 × 10⁻² M with a typical Nernstian slope of 57.89 mV/decade for the mono-cationic drug. The proposed sensor exhibited greenness, as verified via assessment by a recent tool, the Modified Green Analytical Procedure Index (MoGAPI), and the Analytical GREEnness (AGREE) tool. The proposed ion-selective electrode successfully quantified vibegron in tablet form without any remarkable interference from the tablet excipients. This work also demonstrated the first use of electrochemistry during a cleaning validation protocol for monitoring any drug residues to ensure the effective cleaning of pharmaceutical manufacturing equipment with satisfactory recovery values. The proposed sensor was found to be a more sustainable, portable and faster sensing platform for these residues than conventional chromatographic methods.