作者
N.Rohith P. Ravi Sankar, M.M. Eswarudu, P. Siva Krishna, D. Srikanth, P. Srinivasa Babu
发表日期
2021
期刊
Journal of Pharmaceutical Sciences and Research.
卷号
13
期号
5
页码范围
232-237
出版商
Pharmainfo publishers
简介
A simple, reliable, sensitive, precise, rapid, and reproducible RP-HPLC method was developed and validated for the determination of Edoxaban Tosylate Monohydrate (EDTM) in the pharmaceutical dosage form. Separation was achieved under the optimized chromatographic condition on Agilent technologies-1260 infinity system, Eclipse XDB C18 Column,(250 mm× 4.6 mm id, particle size 5 μm, maintained at ambient temperature). The mobile phase consisted of methanol: acetonitrile in the ratio 85: 15 V/V. A gradient elution at a flow rate of 1 mL/minutes using 1260 DAD detector to monitor the elute at 291.2 nm. The retention time of Edoxaban and Tosylate was found to be 3.013 minutes and 1.927 minutes respectively and the calibration curve was a linear function of the drug in the concentration range of 2-10 µg/mL (r2= 0.9997). The limit of detection and the limit of quantitation was found to be 0.2250 µg/mL and 0.6818 µg/mL respectively. The recovery (accuracy) studies were performed and the percentage recovery was found to be 98.8-99.89%. Analytical validation parameters such as selectivity, specificity, linearity, precision, and accuracy were studied and the% RSD value for all key parameters was less than 2%. Thus, the developed reversed-phase HPLC method was found to be feasible for the determination of Edoxaban Tosylate Monohydrate in bulk and pharmaceutical formulations.
引用总数
20212022202320241331
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