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 for the cleaning validation process, in which the selection of a selective, sensitive, easy-to-use, and portable technique is preferred. To this end, a potentiometric solid-contact ion-selective electrode was fabricated for vibegron detection. A smart and effortless approach was firstly adopted for choosing the optimum electrochemical ionophore in the potentiometric sensor. Such theoretical assumptions were practically verified through studying the selectivity of various electrodes with the 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 a mono-cationic drug. The proposed sensor exhibited greenness behavior assured via assessment by the recent tool, the modified green analytical procedure index (MoGAPI) and analytical greenness (AGREE) tools. The proposed ion-selective electrode successfully quantified vibegron in its tablets without any remarkable interference from tablet excipients. The work also witnessed the first employment of electrochemistry during cleaning validation protocol for monitoring any drug residues to ensure the effective cleaning process of the manufacturing pharmaceutical equipments. with satisfactory recovery values. The proposed sensor was found to be a more sustainable, portable and faster sensing platform for such residues than conventional chromatographic methods.