Abstract:

The goal of this study was to create an RP-HPLC method for analysing the anticoagulant rivaroxaban (RIV) and estimating associated degradants in drug and tablet dosage forms that are accurate, sensitive and validated. The analysis was carried out on a Phenomenex Luna C18 column (4.6 x 250mm, 5μm particle size) at 40°C in isocratic mode with mobile phase water and acetonitrile (45:55 v/v) at a flow rate of 1.2 ml/min and a wavelength of 249 nm. This method was validated for linearity and range, accuracy, precision, LOD, LOQ and robustness according to ICH guidelines and the findings were satisfactory. The current study was carried out under various stress circumstances in order to determine the chemical structure of the primary degradation products generated when the drug was exposed to hydrolysis (basic, acidic, neutral), oxidation and photolytic conditions. Retention time (tR) was found to be 4.191±0.01 min. The three primary degradation products D1 (tR shown at 1.813 min), D2 (tR shown at 2.229 min), and D3 (tR shown at 1.850 min) developed during stress conditions in 0.1N NaOH, 0.1N HCl and 30% H2O2, respectively, as revealed by chromatogram and mass spectra. Under the ion spray voltage of 5500 V for positive mode, the molecular ion [M+1] m/z 436.3 of RIV was seen. The fragment ion peak was observed at m/z 415.5, 338.6, and 149.2. In basic, acidic and oxidative environments, RIV was found to be degraded. Quadrapole MS/MS was used to identify these contaminants in drugs and drug products.

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