Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE AND EPLERENONE IN ITS SYNTHETIC MIXTURE

Dr. Avani N. Doshi*, Ms. Honey Patel

Abstract

Metabolic disorders are increasingly recognized as systemic conditions with significant effects on both cardiac and renal health. Type 2 diabetes mellitus substantially contributes to the development and progression of cardiovascular disease and chronic kidney impairment through complex metabolic and hormonal disturbances. [1] Pharmacological agents that influence renal sodium handling have shown potential to modify disease outcomes beyond glycemic control. Dapagliflozin, an inhibitor of sodium–glucose cotransporter-2, facilitates glucose and sodium excretion via the kidneys, leading to beneficial metabolic and hemodynamic effects.[2] Eplerenone, a selective mineralocorticoid receptor antagonist, counteracts aldosterone-driven fluid retention and tissue fibrosis with improved tolerability.[2,3] The concurrent use of dapagliflozin and eplerenone targets distinct yet interrelated pathways within the cardio-renal system and may provide enhanced protective effects in patients with kidney and heart dysfunction.[2,3] Ongoing monitoring of renal function and electrolyte balance remains essential during combined therapy.

Keywords: Dapagliflozin Propanediol Monohydrate; Eplerenone; Type 2 diabetes mellitus; Cardio-renal syndrome; Chronic kidney disease; Fixed- dose combination.