Journal of Chemical and Pharmaceutical Research (ISSN : 0975-7384)

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Original Articles: 2016 Vol: 8 Issue: 12

RP-HPLC Method Development and Validation for Determination of Rivaroxaban in the Pure and Pharmacuetical Dosage Form

Abstract

A simple, rapid, accurate, precise, robust and reproducible reverse phase high performance liquid chromatographic method was developed for the determination of Rivaroxaban in pure drug and pharmaceutical dosage form. The quantification was carried out using enable C18(250×4.6mm,5μm) column in a binary mode with mobile phase comprising 0.1%glacial acetic acid: acetonitrile in 30:70 %v/v at flow rate 1ml/min, detection was carried out at 250nm using PDA detector with injection volume 20μl, the retention time was found to be 3.44min. The proposed method was validated as per ICH Q2B guidelines. The method produced linear response in the concentration range of 2-10μg/ml (R2 ˜0.9993). The recovery studies were carried out and found to be within 98-102%. %RSD was found to be 2%. LOD and LOQ of Rivaroxaban for the method were found to be 0.008μg/ml and 0.248μg/ml respectively. The proposed method was statistically evaluated and can be applied for the routine analysis, quality control of raw materials, formulation of different strengths, dissolution studies and bioequivalence studies for the same formulation of Rivaroxaban.