European Journal of Biomedical and Pharmaceutical Sciences

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHODS FOR APIXABAN IN TABLETS

Kunala Anusha, Gummadi Sowjanya* and Seru Ganapaty

ABSTRACT

Two sensitive zero order (D0) and first order derivative (D1) UV spectroscopic methods have been developed and validated for the determination of Apixaban in pharmaceutical formulations using phosphate buffer pH 5.0 (Method A), and phosphate buffer pH 7.0 (Method B). The drug showed maximum absorbance at 276 nm in zero order and the amplitude was measured in the range of 264 nm - 305 nm in first order derivative. Beer-Lambert’s law was obeyed in the range of 1 – 60 μg/mL. Accuracy of the methods were established by standard addition and the recovery was found to be in the range of 98.3 - 101.1 % (% RSD < 0.66, zero order), 99.06 -100.4 % (% RSD <1.57, first order derivative). Precision of the methods were studied in terms of repeatability and intermediate precision (% RSD < 1.75). The developed methods were successfully applied for the assay of Apixaban in tablets and there was no interference from the excipients. The developed methods were found to be sensitive as observed from the optical characteristics. These methods were validated as per ICH guidelines and can be suitably used for the analysis of Apixaban in API and tablets.

Keywords: Apixaban, Zero Order (D0), First Order Derivative (D1), Validation, ICH guidelines.