Type 2 diabetes can be cured by using tradjenta (also known as Linagliptin), a new therapeutic drug that is an inhibitor of the dipeptidyl peptidase-4 enzyme. Tradjenta is administered orally alone or in combination with metiguanide or empagliflozin. An easy and specific fluorimetric analysis of Tradjenta was developed and demonstrated in the present investigation. The Hantzsch reaction method, which generates a fluorescent dihydropyridine derivative, is the basis of this assay. In a Toerell-Stenhagen buffered solution, the unsubstituted amine group of Tradjenta interacted with 2,4-Pentadione/Oxomethane. Spectrofluorimetry was utilized for this investigation at an excitation/emission wavelength of 421/480 nm. When comparing the Tradjenta concentration to the tracked fluorimetric signal, the method revealed linearity over the concentration range of 0.05 to 1.2 µg/mL. By strictly altering system parameters and analyzing the validation factors following International Council for Harmonisation (ICH) requirements, the outcomes were achieved. Finally, the proposed approach was successfully applied to assay the drug not only in its raw form and prescribed formulations but also to evaluate the tablet's uniformity of content.
Keywords: Dosage form; Fluorimetric assay; Hantzsch derivatization reaction; Method greenness evaluation; Tradjenta.
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