Dissolution Profile of Apixaban Tablets: Method Development and Validation Using HPLC Analysis

Abstract

Apixaban is an anticoagulant agent that inhibits factor Xa, commercially available as coated tablets at the dosages of 2.5 and 5.0 mg. There is no official monograph of the formulation in the current international pharmacopoeias. From research and development to finished product quality control, the dissolution test is an important tool to evaluate the quality of pharmaceutical formulations. This study aimed to develop and validate an in vitro method to assess the dissolution profile of apixaban immediate-release (5 mg) coated tablets. Several conditions were tested in this study until the most suitable one was reached. The selected method included the following parameters: 0.01 M hydrochloric acid (pH 2.3, 500 mL), USP paddle apparatus, 75 rpm, 37 °C, with seven sampling points and a total test time of 90 minutes. Quantitative analysis was performed by high performance liquid chromatography using a previously validated method. The dissolution method was validated following the official guidelines, demonstrating specificity, linearity, precision, accuracy, and robustness. This study enabled the development of an adequate, effective, and reliable method, which contributes to the evaluation of apixaban release in new products and the quality control of formulations containing this drug.