Design and Validation of a UV Spectrophotometric Analytical Method for Apixaban Determination and Additive Interference Effect Examination

Abstract

In this study, a simple, sensitive, and reliable UV-Vis spectrophotometric method was developed and validated for the quantification of the oral anticoagulant apixaban. During the method development phase, the wavelength at which apixaban exhibited maximum absorbance was determined, and absorbance values at different pH levels were examined to establish the optimum analysis conditions. The effect of the additives commonly found in pharmaceutical formulations containing apixaban on its absorbance was evaluated, and the additives caused statistically significant changes ranging from –3.93% to +7.32%. To determine the reliability and analytical performance of the method, stability, intra-day and inter-day reproducibility studies, the linear working range, precision, and accuracy of the method were evaluated. In addition, the recovery of apixaban from the commercial preparation Eliquis® tablets was studied to demonstrate the applicability of the developed method on pharmaceutical preparations. The recovery results indicated that the method provides a reliable alternative for quantifying apixaban in pharmaceutical dosage forms. The results obtained showed that the developed UV-Vis spectrophotometric method can be used effectively in routine quality control analyses and formulation studies of apixaban. The simplicity, economy, and rapidity of the method enable its wide-ranging use.

Keywords

• Apixaban
• UV-Vis spectroscopy
• Pharmaceutical additives
• Analytical method development

References

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