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


ÇELEBİER M. , REÇBER T. , KOÇAK E. , ALTINÖZ S.

BRAZILIAN JOURNAL OF PHARMACEUTICAL SCIENCES, vol.49, no.2, pp.359-366, 2013 (Journal Indexed in SCI) identifier identifier

  • Publication Type: Article / Article
  • Volume: 49 Issue: 2
  • Publication Date: 2013
  • Doi Number: 10.1590/s1984-82502013000200018
  • Title of Journal : BRAZILIAN JOURNAL OF PHARMACEUTICAL SCIENCES
  • Page Numbers: pp.359-366

Abstract

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 (R) (10 mg)). Phenomenex Luna 5 mu m C18 100 angstrom LC Column (250 x 4.6 mm) was used at 40 degrees C. 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 mu g 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.