Author(s):
Saurav R. Dunbale, Deelip V. Derle, Ashlesha A. Wakchaure, Ashwini A. Amrutkar, Amol V. More
Email(s):
sauravdunbale99@gmail.com
DOI:
10.52711/0974-360X.2024.00115 
Address:
Saurav R. Dunbale1*, Deelip V. Derle2, Ashlesha A. Wakchaure1, Ashwini A. Amrutkar1, Amol V. More3.
1Department of Pharmaceutical Quality Assurance, MVP Samaj’s College of Pharmacy, Nashik, Maharashtra, India - 422002.
2Department of Pharmaceutics, MVP Samaj’s College of Pharmacy, Nashik, Maharashtra, India - 422002.
3Department of Pharmaceutical Quality Assurance, Core Analytical Pvt Ltd., Nashik.
*Corresponding Author
Published In:
Volume - 17,
Issue - 2,
Year - 2024
ABSTRACT:
Rivaroxaban is andirect acting oralanticoagulant and factor Xa inhibitor. A simple, selective, precise and rapid RP-HPLC method for estimation of Rivaroxaban (RIVA) in human blood plasma was developed and validated. The sample spike in plasma was extracted using liquid liquid extraction were extracted with the organic solvent ethyl acetate as organic solvent. Apixaban as an internal standard. The compounds were analysed by Agilent HPLC was used with control panel software using UV detector on a Inertsil ODS (250mm x 4.6mm ID;5µ) column with an Flow rate of 1.2mL/min, an isocratic mobile phase consisting of 0.02M Ammonium acetate buffer: Acetonitrile (70:30%v/v). Different sample pre-treatment techniques were evaluated, but Liquid Liquid extraction was found to be satisfactory, with good recovery values of 93.70% for RIVA. The developed method is validated by ICHM10 and USFDA guidelines over the concentration range of 5.00 to 200.00 ng/ml in human blood plasma with R² =0.9993. Within-day precisions and accuracy for RIVA were found in 0.36% to 4.73% and 92.58% to101.82% respectively. The validated RP-HPLC method has been used successfully for both preliminary pharmacokinetic studies and therapeutic drug monitoring
Cite this article:
Saurav R. Dunbale, Deelip V. Derle, Ashlesha A. Wakchaure, Ashwini A. Amrutkar, Amol V. More. Development and Validation of Bioanalytical Method for Estimation of Rivaroxaban using RP-HPLC with Liquid liquid extraction in Human Blood Plasma and its application in Bioequivalence Study. Research Journal of Pharmacy and Technology. 2024; 17(2):739-5. doi: 10.52711/0974-360X.2024.00115
Cite(Electronic):
Saurav R. Dunbale, Deelip V. Derle, Ashlesha A. Wakchaure, Ashwini A. Amrutkar, Amol V. More. Development and Validation of Bioanalytical Method for Estimation of Rivaroxaban using RP-HPLC with Liquid liquid extraction in Human Blood Plasma and its application in Bioequivalence Study. Research Journal of Pharmacy and Technology. 2024; 17(2):739-5. doi: 10.52711/0974-360X.2024.00115 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2024-17-2-43
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