DEVELOPMENT AND VALIDATION OF SIMPLE UV SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF APIXABAN IN API AND ITS BULK DOSAGE FORM

Simple, rapid, sensitive, precise and specific UV spectrophotometric method for the determination of Apixaban in bulk drug and pharmaceutical dosage form were developed and validated. In this method solution of Apixaban was prepared in methanol. Apixaban standard solution was scanned in the UV rang (400-200nm) in a 1cm quartz cell in a double beam UV spectrophotometer. The standard solution of Apixaban showed maximum absorption at wavelength 280 nm. The method obeys Beer’s law in the concentration range from 2 μg/ml -10μg/ml. The correlation coefficient was found to be 0.9967 and regression of the curve was found y = 0.0995x + 0.0149 with excellent recovery 99-104%. Limit of detection and limit of quantitation were found to be 0.186 μg/ml and 0.566μg/ml respectively. The method was validated for several parameters like accuracy, precision as per ICH guidelines. Statistical analysis proved that the methods are repeatable and specific for the estimation of the said drug. These methods can be adopted in routine assay analysis of Apixaban bulk or tablet dosage form.