Development and Validation of a Stability-indicating RP-HPLC Method for the Determination of Rivaroxaban in Pharmaceutical Formulations

作者：Walter Mauricio E; Perobelli Rafaela F; Da Silva Francielle S; Cardoso Junior Clovis D A; da Silva Iorhann S; Dalmora Sergio L^*

来源：Latin American Journal of Pharmacy, 2015, 34(8): 1503-1510.

• cytotoxicity
• reversed-phase liquid chromatography
• rivaroxaban
• validation

A stability-indicating reversed-phase liquid chromatography method (RP-HPLC) was validated for the analysis of rivaroxaban. The method was carried out on a C18 column (150 mm x 4.6 mm i.d.), maintained at 40 degrees C. The mobile phase consisted of acetonitrile and water (70: 30), run isocratically at a flow rate of 0.7 mL/min, and using a photodiode array (PDA) detection at 249 nm. The separation was obtained with retention time of 2.9 min, and was linear over the concentration range of 0.04-200 mu g/mL (r(2) = 0.9992). The specificity and stability-indicating capability of the method were proven through degradation studies. The in vitro cytotoxicity test of the degraded products showed significant differences (p < 0.05). The accuracy was 99.77% and bias lower than 1.67%. The method was applied for the analysis in human plasma and tablet dosage forms.

• 出版日期2015