CHARACTERIZATION OF LINAGLIPTIN USING ANALYTICAL TECHNIQUES

Linagliptin (LGT) is a member of the class of gliptins that inhibit the enzyme dipeptidyl-peptidase-4. They are used to reduce glucose blood levels in patients with type 2 Diabetes mellitus. Due to its recent development and launching on the market, LGT has no official compendium monograph, national or international, or available registries for the qualitative determination of this drug. The objective of this work was to characterize LGT by using thermal techniques, nuclear magnetic resonance, mass and infrared spectrometry, liquid chromatography and ultraviolet spectrophotometry to be used as a chemical reference substance. The range and melting point obtained are in accordance with that described in the literature. The main groups of LGT molecule were observed in infrared spectroscopy and the molecular ion m/z 473.25 ratio was found in mass spectroscopy analysis. In UV spectroscopy, the maximum wavelength absorption of the substance in different solvents can be observed. The chromatographic methods provide selectivity for LGT and can be used to analyze it qualitatively. The proposed conditions have been successfully applied for identification and qualitative analysis of LGT as a chemical reference substance, contributing to studies of this gliptin, and to the quality control of medicines that contain it.