Development and validation of a stability-indicating RP-HPLC method for the determination of Betrixaban in bulk and its laboratory synthetic mixer

A stability-indicating reversed-phase liquid chromatography method ( RP-HPLC) was validated for the analysis of Betrixaban. Analysis was performed on a Waters Alliance 2695 separation module, with waters 2487 UV detector in isocratic mode using Auto sampler. Data collection and processing was done using EMPOWER software version-2. The analytical column used for the separation was Xterra C (18) (4.6 x 150mm, 5.0 mu m), Flow rate was kept at 0.6 ml/min. the column temperature was maintained at Ambient. the mobile phase was made up of Orthophosphoric acid (0.1%) pH 2.1 and Methanol in 10: 90 ratio. The method was optimized at 292nm. Run time was taken as 10 min. The injection volume of samples was 20 mu l. The separation was obtained with retention time of 2.663 min, and was linear over the concentration range of 100-600 ppm (r2 = 0.999). The specificity and stability-indicating capability of the method were proven through degradation studies. The LOD and LOQ of Betrixaban was found to be 3.2 mu g/ml and 9.6 mu g/ml respectively and the statistics data for the Betrixaban was concluded that the method was found to be simple, reliable, selective, reproducible and accurate. The method was successfully used for quality control analysis of Betrixaban.