Analytical Method Development by HPLC to Evaluate the Stress Degradation Stability Profile of Ertugliflozin

Abstract

Diabetes is a chronic disease in which the body does not make or properly utilize the insulin, a hormone that is required to convert blood sugar, starches, and other food into energy by circulate the glucose from blood into the body cells”. People are going on making new drugs and new formulations of the existing drugs within very short period of time. To get the regulatory permission for marketing, company has to submit required data including the analysis reports as to prove that their drug product is of required quality for its intended use. T2DM, the predominant type of diabetes accounting for >90% of all diabetes cases, is a progressive disease involving parallel defects of glucose metabolism in multiple tissues. Common risk factors for T2DM include increasing age, smoking, being overweight or obese, physical inactivity and poor nutrition. Ertugliflozin is an oral, selective inhibitor of sodium glucose co-transporter-2 (SGLT2) which inhibits renal glucose reabsorption and results in urinary glucose excretion (UGE) and reductions in plasma glucose and haemoglobin A1c (A1C) in patients with type 2 diabetes mellitus (T2DM).The present developed analytical method was developed using 0.1% Formic acid in water: 0.1% Formic acid in ACN as the mobile phase. The developed method was found to be sensitive and time and cost effective with the reduced the use of organic chemicals in the mobile phase. Improved stability-indicating RP-HPLC method was developed for the estimation of ertugliflozin. Retention times compared to the best method reported. The developed method could be suitable for routine analysis of the drugs in bulk and tablet formulation after complete validation as per ICH guideline.