Abstract

DEVELOPMENT AND VALIDATION OF AN RP-HPLC METHOD FOR THE DETERMINATION OF APIXABAN IN BULK AND TABLET DOSAGE FORM

Jashwanth Gowda H. U.*, Naveen Kumar G. S.*

ABSTRACT

Reliable analytical techniques are crucial for the quantitative determination of Apixaban, a Anti-Coagulant drug used to Deep vein thrombosis, Pulmonary embolism in pharmaceutical formulations. The goal of the current work was to create and validate a straightforward, accurate, and sensitive reverse-phase high-performance liquid chromatographic (RP-HPLC) method for measuring Apixaban in tablet and bulk medication dosage forms. A Waters C18 column (5 µm, 4.6 × 250 mm) with an isocratic mobile phase made of ammonium formate buffer and Acetonitrile (65:35, v/v) at a flow rate of 1.0 mL/min was used to accomplish chromatographic separation. With an injection volume of 20 µL and a column temperature of 25°C, detection was performed at 280 nm. The method was validated according to ICH guidelines for specificity, linearity, precision, accuracy, robustness, limit of detection (LOD), and limit of quantification (LOQ). Apixaban showed a retention time of 10 mins. The method demonstrated excellent linearity over the range of 10–150%, with a correlation coefficient (R²) of 0.9997 and regression equation Y = 45263x-38270. System and method precision showed %RSD values of 0.132% and 0.779%, respectively. Mean recoveries at 80%, 100%, and 120% levels were 99.4%, 99.0%, and 99.3.%, respectively. The LOD and LOQ were found to be 0.453 and 1.34 µg/mL, respectively. The approach showed adequate robustness, specificity, and system appropriateness. The established RP-HPLC method is appropriate for regular quantitative analysis of Apixaban in bulk medication and pharmaceutical tablet dosage forms since it was found to be straightforward, precise, accurate, sensitive, robust, and free of major excipient interference.

Keywords: Apixaban; Quantification; Validation; RP-HPLC; Anthelmintic.