DEVELOPMENT AND VALIDATION OF BIOANALYTICAL METHOD FOR ESTIMATION OF RIVAROXABAN USING HPLC-PDA IN HUMAN BLOOD PLASMA
Abstract
Rivaroxaban is oral anti-coagulant drug, used in the treatment of various blood disorders. A sensitive and accurate liquid chromatographic methodfor the quantification of rivaroxaban in human plasma was successfully developed. Protein precipitation was used for sample preparation. Quantification of analyte was achieved on phenomenexluna C8 (5µm x 25cm x 4.6mm i.d.) column using methanol:water:dimethyl sulfoxide (50:45:5, v/v/v) as mobile phase at a flow rate of 1ml/min. Detection was achieved at 252nm over the linearity concentration range of 5-40µg/ml. Retention time was found 6.2 min. The LOD and LOQ were found to be 1.5 µg/ml and 4.5 µg/ml, respectively.The developed method was validate as per US FDA guidelines.Â
DOI
https://doi.org/10.22270/jddt.v7i7.1608References
Rohde G, Determination of rivaroxaban--a novel, oral, direct Factor Xa inhibitor--in human plasma by high-performance liquid chromatography-tandem mass spectrometry, J Chromatogr B, 2008, 872, 43-50.
Kuhn J, Gripp T, Flieder T, Dittrich M, Hendig D, Busse J, UPLC-MRM Mass Spectrometry Method for Measurement of the Coagulation Inhibitors Dabigatran and Rivaroxaban in Human Plasma and its Comparison with Functional Assays, PLoS ONE, 2015, 10 (12),78.
Celebier M, Reçber T, Koçak E, Altınöz, Kır S, Determination of Rivaroxaban in Human Plasma by Solid-Phase Extraction–High Performance Liquid Chromatography, J Chrom Sci, 2015, 7, 1-5.
Zhang W, Lou D, Zhang DT, Zhang Y, Huang HJ, Determination of rivaroxaban, apixaban and edoxaban in rat plasma by UPLC–MS/MS method, J Thromb Thrombolysis, 2016, 1-7.
Reddy GS, Prasad RSLN, Reddy LSK, Development and Validation of Hplc-Ms/Ms Method for Rivaroxaban Quantitation in Human Plasma Using Solid Phase Extraction Procedure, Orient J Chem, 2016, 32 (2), 1145-1154.
Published
Abstract Display: 914
PDF Downloads: 781 How to Cite
Issue
Section
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).

.