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


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

BRAZILIAN JOURNAL OF PHARMACEUTICAL SCIENCES, cilt.49, sa.2, ss.359-366, 2013 (SCI-Expanded) identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 49 Sayı: 2
  • Basım Tarihi: 2013
  • Doi Numarası: 10.1590/s1984-82502013000200018
  • Dergi Adı: BRAZILIAN JOURNAL OF PHARMACEUTICAL SCIENCES
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Sayfa Sayıları: ss.359-366
  • Anahtar Kelimeler: HPLC, Rivaroxaban, Validation, System suitability, Stability-indicating, Pharmaceutical dosage form
  • Hacettepe Üniversitesi Adresli: Evet

Özet

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.