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

Suraj Sahoo, Suman Kumar Mekap

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 C19H18ClN3O5S. 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.

Keywords


Rivaroxaban, Validation, RP HPLC, ICH

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References


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DOI: http://dx.doi.org/10.26510/2394-0859.pbe.2017.27

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