• Deepak Patil
• Dr. S. Shobha Rani
• Mahesh Rajendra Awate
• K.S.L.Harika

A specific, precise, and accurate RP-HPLC method has been developed and validated for the quantitative analysis of Rivaroxaban in tablet formulation. A Gradient separation was achieved using a Inertsil C8-3, (150×4.6mm), 5µm column with a flow rate of 1.0 ml/min, The injection volume was 10μL and PDA detector at 254nm.The column and sample temperature was maintained at 25°C. Run time was 20 minutes. The retention time of Rivaroxaban peak was about 10.57 minutes. Gradient elution was performed with mobile phase-A, (Buffer : 1.0 mL of ortho phosphoric acid and 2.163 g of Octane-1-sulfonic acid sodium salt anhydrous (0.01M) in 1000 mL Milli-Q water.)Buffer: Acetonitrile (90:10% v/v) and Buffer and Acetonitrile (25:75% v/v).The Diluent consists of water and Acetonitrile in the ratio of 50:50%v/v. The method was validated for specificity, linearity, precision, accuracy and robustness. The specificity of the method was determined by assessing interference from the placebo and by stress testing the drug product (forced degradation). The method was linear over the concentration range from 25% of target concentration to 225% of target concentration (r2 = 1.000). The method was found to be Robust and suitable for the quantitative analysis of Rivaroxaban in a tablet formulation. Degradation products resulting from the stress studies did not interfere with the detection of Rivaroxaban peak in chromatogram, demonstrating the stability-indicating method.

Rivaroxaban, Stability-indicating, RP-HPLC.

"STABILITY INDICATING ASSAY METHOD DEVELOPMENT AND VALIDATION OF RIVAROXABAN BY RP-HPLC", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.5, Issue 12, page no.559-585, December-2018, Available :http://www.jetir.org/papers/JETIR1812890.pdf

"STABILITY INDICATING ASSAY METHOD DEVELOPMENT AND VALIDATION OF RIVAROXABAN BY RP-HPLC", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.5, Issue 12, page no. pp559-585, December-2018, Available at : http://www.jetir.org/papers/JETIR1812890.pdf