Stress study and estimation of a potent anticoagulant drug rivaroxaban by a validated HPLC method: Technology transfer to UPLC

Hetal Jebaliya, Batuk Dabhi, M

Abstract

This work deals with the method development and val idation of Rivaroxaban in pharmaceutical dosage for m on both the instruments HPLC and UPLC (technology tran sfer HPLC to UPLC) with forced degradation study. I n present method chromatographic separation was perfo rmed using phenomenax C8 100A (250 X 4.6mm id, 5 μ m particle size) HPLC column and acquity UPLC (R) BEH C8 (100 X 2.1mm id, 1.7 μ m particle size) UPLC column with 30°C column oven temperature. The isocratic mo bile phase was consisted 0.1% OPA: ACN (60: 40 V/V) for HPLC and (55: 45 V/V) for UPLC. The detection was m onitored at wavelength of 280 nm. Flow rate consist ed 1ml/min and 0.25 ml/min simultaneously for HPLC and UPLC with 20 μ l and 2 μ l injection volume. The total analysis takes 15 minutes for HPLC and 3 minutes fo r UPLC.