ABSTRACT

A simple, rapid, precise, sensitive and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative analysis of Rivaroxaban in bulk & pharmaceutical dosage form. Chromatographic separation of Rivaroxaban was achieved on Waters Alliance-e2695, by using Agilent SB C18 (250mm x 4.6mm, 3.5?m) column and the mobile phase containing ACN and 0.1% Formic acid in the ratio of 70:30% v/v. The flow rate was 0.8 ml/min; detection was carried out by absorption at 269nm using a photodiode array detector at ambient temperature. The number of theoretical plates and tailing factor for Rivaroxaban were NLT 2000 and should not more than 2 respectively. % Relative standard deviation of peak areas of all measurements always less than 2.0. The proposed method was validated according to ICH guidelines. The RP-HPLC method was found to be linear over the concentration range from 12.5-75 ?g/ml with correlation coefficient of (r2) 0.99978.the retention time for bulk rivarobaxan was found to be 3.029 min. LOQ of method was 0.5 ?g/ml and LOD of method was found to be 0.15 ?g/ml. The method was found to be simple, economical, suitable, precise, accurate & robust method which can be applied for the regular analysis of rivarobaxan in bulk as well as pharmaceutical dosage form. Keywords: RP-HPLC, Rivaroxaban, Retention time, Formic acid
Publication date: 01/08/2025

https://ijbpas.com/pdf/2025/August/MS_IJBPAS_2025_9297.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.8.9297