Newer Approaches for Analytical Method Validation of Anti Diabetic Agents: A Review

Diabetes refers to a metabolic disorder identified by Hyperglycemia. Dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors) are also called as Gliptins are a relatively new class of antidiabetic drugs to treat type-2 diabetes. Analytical method development and validation play an indispensable role in analysis and manufacture of pharmaceuticals. The intent of this article is to study the reported analytical methods in the literature for assessment of Dipeptidyl peptidase- 4 inhibitors. This review covers divergent analytical methods for the estimation of these drugs. Many spectroscopic and chromatographic techniques are available for the determination and evaluation of these drugs in bulk and pharmaceutical preparation. Newly evolved and advanced chromatographic techniques are also available for the estimation of these drugs in biological fluids such as Liquid Chromatography- Tandem Mass Spectroscopy (LC- MS/MS), Gas Chromatography- Mass Spectroscopy (GC- MS), High Performance Liquid Chromatography- Mass Spectroscopy (HPLC-MS) and Ultra- Fast Liquid Chromatography (UFLC). The development and validation of analytical methods is imperative for drug development studies and even for the development of drug formulation including stability and degradation studies and also for the determination of pharmacokinetic data of these drugs. This review work summaries the current position of analytical methods for estimation of these antidiabetic drugs in bulk, dosage form and biological fluids.