Vildagliptin, a pyrrolidine derivative, chemically known as (S)-1-N-(3-hydroxy-1-adamantyl) glycyl pyrrolidine-2-carbonitrile, belongs to the dipeptidyl peptidase-4 (DPP-4)inhibitor class of drugs.1 The drug is a potent antidiabetic agent that enhances glycemic control by preventing the inactivation of incretin hormones like glucose dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1), as GLP-1 and GIP increase the secretion of insulin in the beta cells and decrease glucagon release by the alpha cells of the islets of Langerhans in the pancreas 2-3
The gut incretin hormones are secreted in the human small intestine after taking a meal and responsible for insulin release in response to increased glucose levels. As the release of insulin by GLP-1 is glucose dependent so it has lower risk of hypoglycemia. However, the clinical use of GLP-1 is limited by its short half-life (2 minutes) due to rapid degradation by the proteolytic enzyme DPP-IV. To improve GLP-1 activity, inhibition of the DPP-IV enzyme is a good therapeutic approach in the treatment of diabetes. Administration of Vildagliptin enhances the ability of GLP-1to produce insulin in response to elevated concentrations of blood glucose, inhibit the release of glucagon following meals.4
Literature survey revealed that very few established analytical methods such as UV spectrophotometry 5, HPLC 6-10 and LC-ESI-MS/MS11-12 methods have been reported for the estimation of Vildagliptin. There is no reported study on the vildagliptin degradation kinetics and room temperature half-life under stress conditions. Thus, our study aim to develop a simple, rapid, precise and accurate HPLC stability-indicating assay to determine vildagliptin in its bulk and dosage form and to study its detailed stress condition outcome as well as its degradation kinetics and room temperature half-life.