Assay comparison of rivaroxaban by new HPLC method with an existing method in tablet dosage form

Pharmaceutical and Biological Evaluations Pub Date : 2017-06-01 DOI:10.26510/2394-0859.PBE.2017.27

S. Sahoo, S. K. Mekap

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引用次数: 7

Abstract

Objective: In the present work, RP-HPLC procedure is optimized to finalize a different approach for the estimation of rivaroxaban in tablet dosage form. A novel drug rivaroxaban used as anti-coagulant in the patients for the prevention of thromboembolism. Methods: The molecule is identified with the molar mass of 435.882 g/mol and molecular formula C 19 H 18 ClN 3 O 5 S. The determination was executed by C18 column (Phenomenex 250 x 4.6 mm, 5 μm maintained at 35°C) at 251 nm with a mobile phase (ACN: Water, 55:45 v/v) and flow of 1.2 ml/min. Results: The retention time found to be about 3.8minutes.The validation parameters performed as per ICH guidelines and found to be within acceptance criteria. Linearity of the method is found to be accepted across five concentration level i.e. being studied by calibration curve. Accuracy was executed at three different concentrations, the amount being recovered are close to 100%. The % RSD values obtained for repeatability, intermediate and reproducibility under precision are within acceptance criteria. Conclusions: The method was accurate, precise, robust and rapid for quantitative determination of rivaroxaban by High Performance Liquid Chromatography.

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利伐沙班片剂剂型HPLC测定方法与现有方法的比较

目的:优化反相高效液相色谱(RP-HPLC)方法，建立利伐沙班片剂含量测定的新方法。一种新型药物利伐沙班作为抗凝剂用于预防血栓栓塞。方法:分子质量为435.882 g/mol，分子式为c19h18cln3o5 s。色谱柱为C18柱(Phenomenex 250 × 4.6 mm，保持温度为5 μm, 35°C)，色谱柱为251 nm，流动相为ACN:水，55:45 v/v，流速为1.2 ml/min。结果:留置时间约3.8min。验证参数按照ICH指南执行，并符合验收标准。该方法在五个浓度水平上的线性是可以接受的，即通过校准曲线进行研究。在三种不同浓度下进行了准确度测试，回收率均接近100%。精密度下重复性、中间性和再现性的% RSD值均在可接受标准内。结论:该方法准确、精密度高、稳健性好，可用于高效液相色谱法测定利伐沙班的含量。

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Pharmaceutical and Biological Evaluations

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