ABSTRACT

Objective: The Therapeutic Goods Administration approved rivaroxaban in November 2008 to treat and avoid deep vein thrombosis (DVT). It is an oxazolidinone compound with anticoagulant action that functions by preventing the body from producing blood clots. The goal of the current research was to create a novel, straightforward, accurate, reliable, precise, and quick RP-HPLC method and then validate it by the ICH criteria for the determination of Rivaroxaban including both bulk and pharmaceutical dosage forms. Methods: High-Performance Liquid Chromatography was used to analyze rivaroxaban. Using an INERTSIL C8 column (150x4.6mm, 5m), a mobile phase composed of KH2PO4 and methanol in the ratio of (60:40 v/v) at a flow rate of 1 ml per minute, and detection performed at the wavelength of 249nm using a UV/Visible detector, improved drug separation was made possible. Results: Rivaroxaban's retention time (Rt) was discovered to be 2.667 minutes. The correlation coefficient (r2) of the method's linearity in the 05–30 ?g/ml range was found to be 0.9996. According to calculations, the method's LOD and LOQ are 0.005 ?g/ml and 0.016 ?g/ml, respectively. The precision studies were estimated, the results were calculated as percent RSD values, and it was discovered that they were within 2% of the acceptable range. Rivaroxaban's mean Recovery was determined to be 99.3%, confirming the effectiveness of the procedure. Conclusion: According to ICH criteria, the designed RP-HPLC technique was verified. Rivaroxaban can be analyzed using the established approach in both its bulk and commercial form. Keywords: Rivaroxaban, RP-HPLC, deep vein thrombosis (DVT)
Publication date: 01/08/2023

https://ijbpas.com/pdf/2023/August/MS_IJBPAS_2023_7347.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.8.7347