In silico and in vitro evaluation of the potential genotoxic impurities of vildagliptin

• DOI: 10.1007/s00210-024-03781-6
• Publication Date: 2025-01-21T08:56:55Z
• Authors: Muhammed Hamitoğlu; Gulcin Tugcu; Ayşe Gökçen Kılıç; Gülşah Esen; Ahmet Aydin
• Keywords: Clastogen; Vildagliptin; Ames test

Abstract Establishing the safety of impurities in drug substances or products is crucial. The assessment genotoxicity for these and determining acceptable limits pose considerable challenges, as recognized recent guidelines. While profile vildagliptin—an oral hypoglycemic drug—is well established, there limited knowledge about genotoxic potential its impurities. In this study, vildagliptin cyclic amidine, diketopiperazine, amide were assessed silico vitro mutagenic clastogenic/aneugenic using Ames micronucleus tests. None investigated showed clastogenic potential, thus, are considered non-mutagenic non-clastogenic/aneugenic vitro. These findings consistent with negative predictions mutagenicity clastogenicity/aneugenicity vitro, indicating a good correlation between data. conclusion, study provides valuable information vildagliptin, confirming that neither nor mutagenic.