Analytical method development and validation of rivaroxaban in bulk and pharmaceutical dosage form by using RP-HPLC

Abstract

A simple, specific, accurate, and precise reverse phase high performance liquid chromatography (RP-HPLC0 method was developed and validated to analyse Rivaroxaban bulk dosage form. Using  Sun Q C18  HPLC column separation was carried out. This was maintained at ambient temperature. During separation mobile phase consist of Acetonitrile : Buffer(sodium acetate buffer) 80:20 was delivered at a flow rate of 1mL/min. Using UV detector analysis was carried out at the wavelength 249 nm. RP-HPLC method was validated by using various parameter like system suitability, linearity, specificity, precision, limit of detection, limit of quantification and robustness. The RP-HPLC method was found to be linear over the concentration range from 5-30 µg/mL (r2 =0.994). Retention time for bulk rivaroxaban was found to be 3.69 min. LOQ of method was 1.331 µg/mL and LOD 0.439 µg/mL. Thus the developed RP-HPLC method was found to be robust which can be applied for the regular analysis of Rivaroxaban in the bulk as well as pharmaceutical dosage form