Comprehensive and robust stability-indicating reversed phase high performance liquid chromatography (RP-HPLC) method for Rivaroxaban: synergistic integration of infrared spectroscopy and clinical pharmacology insights

Rivaroxaban is a novel oral anticoagulant that selectively and directly inhibits factor <i>Xa</i>. A method has been developed and validated for its analysis, adhering to guidelines from the International Conference on Harmonisation (ICH) and the U.S. Pharmacopeia (USP). The validation process assessed parameters such as specificity, robustness, linearity, accuracy, precision, limit of detection (LOD), and limit of quantitation (LOQ). The LOD for impurities and degradants was determined to be 0.3 ppm, while the LOQ was 1 ppm. This stability-indicating method is highly suitable for routine quality control and analytical applications in both raw materials and finished drug products, owing to its simplicity, efficiency, and robustness.