Pre-Formulation Study, Analytical Method Development And Validation Of Rivaroxaban

Abstract

The main objective was to develop and validate the UV-spectrophotometric method for the estimation of rivaroxaban (RIV). Method was validated for different parameters like linearity, precision, and ruggedness study. Calibration curve was constructed for RIV standards by plotting the concentrations versus peak area ratios. The graph proved that the method was linear in investigation concentration range with correlation coefficient R² value of 0.9863 The intraday and interday precision (RSD %) was found to be 1.49 and 1.11% respectively. The robustness were changed relatively between 99.8 – 102.4% within these small changes on mobile phase component and column temperature. The results were evaluated statistically, and there were no significant differences (p>0.05) within the results. Applying same procedures by two different operators showed the ruggedness of the developed method. The analysis results having no significant difference indicate that the proposed method is robust. The FTIR spectra of rivaroxaban was performed and analysed. Results of IR confirmed the presence of the main functional group