RP- HPLC METHOD DEVELOPMENT AND VALIDATION FOR DETERMINATION OF RIVAROXABAN IN THE PURE AND PHARMACUETICAL DOSAGE FORM

R. Nageswara Rao 1*, L Sivasankar Reddy2 and R. Meenakshi2

A simple, rapid, accurate, precise, robust and reproducible RP-HPLC method was developed for the determination of Rivaroxaban in pure drug and pharmaceutical dosage form. The quantification was carried out using enable C18 (250×4.6mm, 5µm) column in a binary mode with mobile phase comprising 0.1% GAA : ACN in 30:70 %v/v at flow rate 1ml/min, detection was carried out at 250nm using PDA detector with injection volume 20µl, the retention time was found to be 3.44min.The method produced linear response in the concentration range of 2-10µg/ml (R2 ˜0.9993). The recovery studies were carried out and %RSD was found to be 0.21. LOD and LOQ of Rivaroxaban for the method were found to be 0.008µg/ml and 0.248µg/ml respectively. The proposed method was statistically evaluated and found to be highly sensitive, precise, accurate, robust and fast. The shorter retention time allows the analysis of large number of samples in short period of time and it is cost effective, so it can be successfully applied for routine analysis of quality control of raw materials and formulation of different strengths of Rivaroxaban.