Development and validation of RP-HPLC method for simultaneous estimation of aspirin and rivaroxaban in synthetic mixture

A Simple, sensitive, rapid, precise and accurate RP-HPLC method has been developed and validated for simultaneous estimation Aspirin and Rivaroxaban in synthetic mixture. The separation process was developed under optimized chromatographic conditions using a reversed phase of C18 column and a mobile phase consists of acetonitrile and water (65:35v/v) adjusted to pH 5.6 with The acetate buffer, flow rate used was (1.1ml/min), the temperature was 27°C and UV detection at 245nm. The retention time of Aspirin and Rivaroxaban was found to be 2.1min and 3.2min respectively. Developed method was validated according to ICH Q2 (R1) guidelines. The method was found to be linearity (R²>0.999) in the concentration range of (10 – 600) μg/ml for Aspirin and (10-100) μg/ml for Rivaroxaban. The precision (intra-day, inter-day) data of this method was found to be within limits (% RSD < 2%), The mean recoveries obtained for aspirin and Rivaroxaban were (99.60 - 101.10)% respectively, so developed method was found to be accurate.