Abstract

A REVIEW ON UV SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF THE DISSOLUTION PROFILE OF RIVAROXABAN

B. Swapna*, Priyanka Kore, T. Poojitha and P. Rasagnya

ABSTRACT

Rivaroxaban is an oral anticoagulant and the first available orally active direct Factor Xa inhibitor with high selectivity. It also inhibits prothrombinase-bound and clot-associated Factor Xa in a concentration-dependent manner. Clinical studies have demonstrated its predictable anticoagulant effects and dose-proportional responses in humans, with a rapid onset of action (within 2-4 hours) and a half-life of (7-14 hours) for young and elderly individuals, respectively. For a 10 mg dose, rivaroxaban exhibits high oral bioavailability (80-100%), unaffected by food intake. It has a dual elimination pathway, with approximately one-third of the unchanged active drug excreted via the renal route. Rivaroxaban is a substrate of CYP3A4 and p-glycoprotein, making it unsuitable for concurrent use with strong inhibitors of both pathways. Rivaroxaban is currently approved for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Studies using a 10 mg once-daily dose have shown its suitability across a broad range of patients, regardless of age, gender, or body weight. Common uses include stroke and blood clot prevention in individuals with non-valvular atrial fibrillation, treatment of acute coronary syndrome, and prevention of blood clots after hip or knee replacement surgery. In this study, UV spectrophotometric method was developed to determine rivaroxaban content in pharmaceutical formulations and the amount released during dissolution studies. The validated method successfully characterized the dissolution profile of rivaroxaban.

Keywords: Rivaroxaban; UV spectroscopy; tablet dissolution, validation.