Development and Validation Of Analytical Methods For The Estimation Of Anti diabetic Drugs

Abstract

newline Type 2 Diabetes mellitus (T2DM) is the most prevalent metabolic disease worldwide. newlineInadequate management and control of hyperglycemia in patients with T2DM may lead to the newlinerisk of developing complications over the long term due to chronic and progressive nature of newlinethe disease arising from pathophysiology of beta-cell dysfunction, insulin resistance and newlineincreased hepatic glucose output. Patients with T2DM often require a combination of newlinetherapeutic agents in order to achieve glycemic control over the long term. newlineFixed-dose combination (FDC) therapies have been shown to improve adherence by reducing newlinecosts, pill burden, and the complexity of treatment regimen. A treatment approach with a newlineFDC that includes combination of anti-diabetic medications could be used to obtain adequate newlineglycemic control in patients with type 2 diabetes. A combined formulation consisting of newlinemetformin, sitagliptin and glimepiride in a single tablet would potentially offer increased newlinepatient convenience and subsequent potential for increased therapeutic compliance and can newlinebe studied for the treatment of adults with inadequately controlled T2DM to improve newlineglycemic control. A clinical trial was conducted for evaluation of sitagliptin in combination newlinewith metformin and sulfonylurea. The aim of that clinical trial protocol was to determine the newlinenon-inferiority of the effectiveness of sitagliptin compared to a control group of patients newlinetreated with thiazolidinedione as add-on therapy, in low-income ethnic minority type 2 newlinediabetic patients who are failing to maintain adequate control with maximal doses of newlinemetformin and a sulfonylurea agent. newlineStability indicating method development and validation for the simultaneous estimation newlineof various anti-diabetic drugs and their combinations: newlineAdvantages of simultaneous stability studies are the identification of new degradation newlineproducts, to understand mutual induction and/or inhibition of rates of degradation and to newlineanalyze the degradation products of both drugs. Various ultraviolet spectroscopic and hig