A Review on HPLC Method Development and Validation for Gliptin Class: New Oral Antidiabetic Agents

Abstract

Gliptin is the class of antidiabetic medicine also called as dipeptidylpeptidase-4. DPP-4 (dipeptidyl peptidase-4) inhibitors (or "gliptins") represent a class of oral anti-hyperglycaemic agents that inhibit the enzyme DPP-4, thus augmenting the biological activity of the "incretin" hormones (glucagon-like peptide-1 [GLP-1] and glucose-dependent insulinotropic polypeptide [GIP]) Sitagliptin, Saxagliptin, Alogliptin, Linagliptin, Vildagliptin are the Gliptin class inhibitor for the treatment of type 2 diabetes mellitus and they decrease the breakdown of the incretin hormones such as glucagon like peptide 1 (GLP-1). All together gliptins have a good oral bioavailability which is not significantly influenced by food intake. PK/pharmacodynamics characteristics, that is, sufficiently prolonged half-life and sustained DPP-4 enzyme inactivation, generally allow one single oral administration per day for the management of T2DM; the only exception is vildagliptin for which a twice-daily administration is recommended because of a shorter half-life DPP-4. This paper is an updated review, providing an analysis of both the similarities and differences between the various compounds known as gliptins, currently used in the clinic (sitagliptin, saxagliptin, alogliptin linagliptin and vildagliptin). This paper discusses the pharmacokinetic and pharmacodynamic characteristics of gliptins. In this review we complied analytical method development and determination of the Gliptin inhibitors. Table no.1, 2, 3, 4, 5, shows the analytical method development and validation of Sitagliptin, Saxagliptin, Alogliptin, Linagliptin, and Vildagliptin alone and with its combination by the HPCL method.