Abstract

SPECTROSCOPIC INVESTIGATION AND VALIDATION OF ACTIVE PHARMACEUTICAL INGREDIENT IN PURE FORM AND IN MARKETED FORMULATIONS

Kumar Raja Jayavarapu*, M. Venkata Satya Sai Kiran, Md Fardeen Pasha, P. Prathyumna, P. Swathi, P. Sai Lakshmi and T. Satyanarayana

Abstract

Rivaroxaban is an anticoagulant medication (blood thinner) used to treat and prevent blood clots. Rivaroxaban inhibits both free and bound Factor Xa in the prothrombinase complex. It is a selective direct factor Xa inhibitor with an onset of action of 2.5 to 4 hours. This paper describes a simple, accurate, specific and validated method for the estimation of Rivaroxaban in pure and in tablet dosage form. A simple study was carried out of all the parameters established as per ICH guidelines to validate an analytical method for estimation. The method showed high sensitivity with reproducibility in results. The wavelength maxima (λmax) was found to be 250 nm. The linearity for this method was found to be in the range of 2 – 10μg/ml. The calibration curve (Fig -2) was drawn by plotting graph between absorbance and concentration. This method showed a correlation coefficient of 0.9997. The regression equation of the curve was Y= 0.02897x+0.05032. Method was successfully validated. In addition, this proposed method was simple, sensitive, and easy to apply and requires relatively inexpensive instruments. The proposed method can be used for routine analysis of Rivaroxaban in bulk as well as in the commercial formulations.

Keywords: Rivaroxaban, UV Spectroscopy, Tablet dosage form, Prothrombinase, Statistical validation, ICH Guidelines.