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Method development and validations of Apixaban in bulk and its formulations by UV-spectroscopy (area under curve)
1  Department of Pharmaceutical Chemistry, School of Pharmacy, Anurag Group of Institutions, Venkatapur, Ghatkesar, Telangana, India 500088.


The aim of the present research work is to validate the apixaban content in bulk and pharmaceutical dosage formulation and validate it as per ICH guidelines. A simple, rapid, precise and highly selective spectrophotometric method was developed for estimation of apixaban in tablet dosage form by Area Under Curve method. Area Under Curve method, involves the measurement of absorbances of apixaban at the wavelength of 269 nm-289 nm. Methanol was used as solvent. Linearity was observed in the concentration range of 5–25 µg/ml for apixaban. The accuracy of the method was confirmed by recovery studies of tablet dosage forms and was found to be 100% for Apixaban. The method showed good reproducibility and recovery with % RSD less than 0.988%. The LOD of apixaban was found to be 0.335 µg/ml and LOQ of apixaban was found to be 1.015 µg/ml. Thus the proposed method was found to be rapid, specific, precise, accurate and cost effective quality control tool for the routine analysis of Apixaban in bulk and tablet dosage form. Drug stability studies have been determined for the formulation under specified conditions and it was found stable.

Keywords: Apixaban, area under curve, analytical method validation, ICH Q2 (R1) guideline.