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Browsing Química by Author "Alfonso González, José Guillermo"
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Item Desarrollo de un método por HPLC indicativo de estabilidad para la cuantificación de Rivaroxabán y sus productos de degradación en formas de dosificación farmacéuticas(Universidad Santiago de Cali, 2020) Alfonso González, José Guillermo; Martínez Betancourt, Jose Alfredo; Castillo Ayala, Jorge Enrique (Director); Barón Valois, Gisel (Codirectora)Rivaroxaban is an anticoagulant drug that acts at a crucial point in the blood clotting process and stops the formation of blood clots in patients with orthopedic surgeries. Simple, fast and reliable reverse phase HPLC methods were developed and validated for the quantification of Rivaroxaban and its degradation products in coated tablets. It was possible to obtain a specific procedure for the analysis under the pertinent conditions, thus complying with current regulations. Rivaroxaban was subjected to conditions of forced degradation demonstrating the stability indicator nature of the methods. The calibration curve for the assay analysis was linear in the range of 70.0 - 130.0μg/mL with a correlation coefficient of 0.999 and for the dissolution test it was 5.5 - 24.1μg/mL with a correlation coefficient of 0.999. The calibration curve for the Related Substances system was linear in the range of 0.2 - 1.2μg/mL with a correlation coefficient of 0.999. Average recovery for Rivaroxaban in tablet dosage form was 99.9%. The above-mentioned methods were easy to apply, which made them well suited for routine analysis of Rivaroxaban coated tablets and could also be used reliably for drug determination in other pharmaceutical dosage forms.