A new HPLC-UV analytical method for apixaban was validated according to ICH guidelines, proving to be specific, linear, accurate, and precise for stability studies and routine quality control.
A new HPLC-UV method was successfully validated as a stability-indicating method for routine quality control of apixaban in liquid pharmaceutical forms.
ABSTRACT Apixaban is a new generation oral anticoagulant drug, which selectively inhibits the coagulation factor Xa. Currently, there is no official monograph available in the pharmacopoeias for apixaban finished pharmaceutical form, allowing stability study. Therefore, the objective of this study was to validate a new simple analytical method by HPLC‐UV detection for apixaban stability study. Our method was issued from the USP monograph under elaboration, which consisted of (ODS‐3V)‐C18 column (250 mm × 4.6 mm, 5 μm), and a mobile phase at polarity gradient composed of ammonium acetate solution at 0.77 g/L and acetonitrile (80:20, v/v) as mobile phase A and acetonitrile as a mobile phase B. The flow rate was set at 1 mL/min, the injection volume at 10 μL, the wavelength at 280 nm, and the temperature at 45°C. The obtained results showed that apixaban was relatively stable under degradation conditions involving temperature, oxidation and UV. However, it was less stable under acidic and basic hydrolysis. Our method was then validated according to the ICH guidelines that were proved to be specific, linear, accurate and precise. Hence, it can be considered as a stability indicating method and suitable also for routine quality control analysis of apixaban in liquid pharmaceutical forms.
Bellaaj et al. (2026) studied this question. HPLC-UV analytical method was evaluated on Method validation (specificity, linearity, accuracy, precision). A new HPLC-UV analytical method for apixaban was validated according to ICH guidelines, proving to be specific, linear, accurate, and precise for stability studies and routine quality control.