DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF APIXABAN IN BULK AND PHARMACEUTICAL DOSAGE FORMS

In the present work a simple, accurate and precise UV Spectrophotometric method has been developed for determination of Apixaban1-2 in bulk and pharmaceutical formulations. The optimum conditions for the analysis of drug are established and Apixaban is found to exhibit maximum absorption at 282 nm with DMSO as a solvent. The present method is validated as per guidelines of the International Conference on Hormonization (ICH) guidelines3-5 including parameters like linearity, accuracy, precision, limit of detection and limit of quantification. Drug obeyed Beer's law in concentration range of 5-20 µg/ml and the regression equation is found to be Y=5.741X-0.071 with correlation coefficient 0.999. From the results it is observed that good correlation exist between drug concentration and absorbance. The percent recovery of Apixaban is found to be 98.5-99.5. The precision is evaluated and relative standard deviation (RSD) is less than 2%, LOD & LOQ are 0.295 & 0.895 respectively. The method is applied to marketed formulation (Eliquis) and Apixaban content is found to be 99.35 with respect to labeled claim. The results suggest that this method can be employed for routine analysis of Apixaban in bulk and commercial pharmaceutical formulations. Key words: Apixaban, DMSO, Spectrophotometric method and Validation