Metabolism and Chemical Degradation of New Antidiabetic Drugs (Part II): A Review of Analytical Approaches for Analysis of Gliptins.

This paper is part II of the review on metabolism and chemical degradation of new antidiabetic drugs from glutides, gliflozins and gliptins. It is well known that metabolism data can be helpful for deriving safe levels of degradation impurities and their qualifying as far as toxicological aspects are concerned. As a result, it could link the quality of respective pharmaceutical products to clinical practice and patients. Some overlapping pathways of transformations of these important drugs of different chemical structures and different mechanisms of action were discussed. At the same time, the paper summarized interesting analytical tools for conducting modern drug metabolism as well as drug degradation experiments. The methods described here include liquid chromatography (LC) and liquid chromatography coupled with mass spectrometry (LC-MS or LC-MS/MS), which are widely used for detection and quantitative measurements of the drugs, their metabolites and degradants, as well as radiometric methods that are suitable for pharmacokinetic experiments. Special attention was paid to dedicated types of packing in chromatographic columns, as well as to special solutions in the LC-MS procedures. The present part addresses the analytical approaches elaborated for examining the metabolism and degradation pathways of gliptins that are dipeptidyl peptidase 4 (DPP-4) inhibitors.