Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF RIVAROXABAN IN BULK AND TABLET DOSAGE FORM

Amelia M. Avachat and Milind B. Yamgar*

ABSTRACT

A reversed-phase high performance liquid chromatography (RP-HPLC) method was developed and validated for the estimation of rivaroxaban in bulk and tablet dosage forms. The separation was achieved on stainless steel Purospher® STAR Hibar® C18 analytical column (250 mm × 4.6 mm i.d., 5.0 μm) using acetonitrile and water in the ratio 80:20 v/v as mobile phase and at a flow rate of 1 mL/min. Detection was carried out using a UV detector at 247 nm. The method was validated for accuracy, precision, linearity, LOD, LOQ and robustness. Validation studies demonstrated that this HPLC method is simple, specific, rapid, reliable and reproducible. The standard curve was linear over the concentration range of 10-70μg/mL with R2 close to one (0.996). The limit of detection (LOD) and limit of Quantitation (LOQ) obtained for rivaroxaban were0.009381μg/mL and 0.078621μg/ mL, respectively. The developed and validated method was successfully applied for the quantitative analysis of Rivaroxaban tablets. This method can be used as more convenient and efficient option for the analysis of rivaroxaban to establish the quality of the drug substance during routine analysis with consistent and reproducible results.

Keywords: RP-HPLC method, Validation, Rivaroxaban, Assay.