Abstract

UV SPECTROSCOPY METHOD DEVELOPMENT AND VALIDATION FOR DETERMINATION OF RIVAROXABAN IN BULK AND PHARMACEUTICAL DOSAGE FORM

Afaque Ansari, Vaibhav Jadhav*, Ravishankar Chadchankar, Shivprasad Patil and Shivshankar Wale

ABSTRACT

The present study was undertaken to develop a spectrophotometric method for the determination of rivaroxaban in pharmaceutical dosage forms. This paper describes a simple, rapid, accurate, and precise UV-spectrophotometric method for the assay of rivaroxaban in bulk and marketed dosage forms. The validation of the developed method was carried out according to ICH guidelines concerning linearity, precision, accuracy, specificity, the limit of detection, and the limit of quantification. The diluent is acetonitrile and water. Calibration curves were obtained in the concentration range of 05-10 μg/ml for rivaroxaban and with good correlation coefficients (R2=0.9994). The precisions of the new method for the drug were less than the maximum allowable limit (%RSD < 2.0) specified by the ICH. Therefore, the method was found to be accurate, reproducible, and sensitive for the analysis of rivaroxaban in pharmaceutical dosage forms.

Keywords: UV spectroscopy, method development, and validation, Formulation, rivaroxaban.