Brazilian Journal of Pharmaceutical Sciences (Jun 2013)

RP-HPLC method development and validation for estimation of rivaroxaban in pharmaceutical dosage forms

  • Mustafa Çelebier,
  • Tuba Reçber,
  • Engin Koçak,
  • Sacide Altinöz

DOI
https://doi.org/10.1590/S1984-82502013000200018
Journal volume & issue
Vol. 49, no. 2
pp. 359 – 366

Abstract

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Rivaroxaban, an anti-clotting medication, acts at a crucial point in the blood-clotting process and stops the formation of blood clots. In this study, RP-HPLC method was developed for the determination of rivaroxaban in tablets (Xarelto® (10 mg)). Phenomenex Luna 5 µm C18 100 Å LC Column (250 x 4.6 mm) was used at 40 ºC. Isocratic elution was performed with ACN:Water (55:45 v/v) mixture. The flow rate was 1.2 mL min-1 and UV detection was at 249 nm. Internal standard (Caffeine) and rivaroxaban were eluted within 2.21 and 3.37 minutes, respectively. The developed method was validated according to the ICH guidelines and found to be linear within the range 0.005 - 40.0 µg mL-1. The method was accurate, precise, robust and rapid. Thus, it was applied successfully for the quality control assay of rivaroxaban in tablet dosage form.

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