Analytical Method Development And Validation Of Assay Of Anticoagulant Drug Edoxaban By Rp-hplc Method

Bhagyashree Sunil Mundhe, Harshala Dhanraj Salve, Ashwini Shelke, Anil Jadhav

Page No: 10-15

The aim of this study is to develop a sensitive, specific, rapid, and precise reverse phase high performance liquid chromatography (RP-HPLC) method and validate it for Edoxaban an anticoagulant drug. The chromatographic separation was achieved on the analysis of the drug was carried out on Agilent 1100 Series HPLC Isocratic System with Auto injector, UV (PAD) detector, C18 column (4.6mm x 250 mm; 5 µm), a 20µl injection loop and running Chemstation software. Different solvents of varying polarity in different proportions were tried as trial and error as Mobile phase for development of the chromatogram. The selection of the wavelength was based on λ max obtained scanning of Sample solution in MeOH. The system gave the good optimized result, resolution & optimum retention time with an appropriate purity, tailing factor, Theoretical plates and symmetry. Therefore optimized method with HPLC column C8 along with runtime of 7 min, Mobile phase Methanol, flow rate 1.5ml/min, The column oven temperature maintain at 35 °C, the PAD detector maintain at 289 nm with good optimized result, effectively, successfully, efficiently, resolution and Retention time 2.058, Theoretical Plates 5685, Symmetry Factor 0.81 and purity 996.41. The developed method was validated as per ICH guidelines and found to be specific, precise, sensitive, and robust.

Citations

APA: Bhagyashree Sunil Mundhe, Harshala Dhanraj Salve, Ashwini Shelke, Anil Jadhav (2025). Analytical Method Development And Validation Of Assay Of Anticoagulant Drug Edoxaban By Rp-hplc Method. DOI: DOI:10.86493/OTJ.2534102

AMA: Bhagyashree Sunil Mundhe, Harshala Dhanraj Salve, Ashwini Shelke, Anil Jadhav. Analytical Method Development And Validation Of Assay Of Anticoagulant Drug Edoxaban By Rp-hplc Method. 2025. DOI: DOI:10.86493/OTJ.2534102

Chicago: Bhagyashree Sunil Mundhe, Harshala Dhanraj Salve, Ashwini Shelke, Anil Jadhav. "Analytical Method Development And Validation Of Assay Of Anticoagulant Drug Edoxaban By Rp-hplc Method." Published 2025. DOI: DOI:10.86493/OTJ.2534102

IEEE: Bhagyashree Sunil Mundhe, Harshala Dhanraj Salve, Ashwini Shelke, Anil Jadhav, "Analytical Method Development And Validation Of Assay Of Anticoagulant Drug Edoxaban By Rp-hplc Method," 2025, DOI: DOI:10.86493/OTJ.2534102

ISNAD: Bhagyashree Sunil Mundhe, Harshala Dhanraj Salve, Ashwini Shelke, Anil Jadhav. "Analytical Method Development And Validation Of Assay Of Anticoagulant Drug Edoxaban By Rp-hplc Method." DOI: DOI:10.86493/OTJ.2534102

MLA: Bhagyashree Sunil Mundhe, Harshala Dhanraj Salve, Ashwini Shelke, Anil Jadhav. "Analytical Method Development And Validation Of Assay Of Anticoagulant Drug Edoxaban By Rp-hplc Method." 2025, DOI: DOI:10.86493/OTJ.2534102