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Provedor de dados:  BJPS
País:  Brazil
Título:  RP-HPLC method development and validation for estimation of rivaroxaban in pharmaceutical dosage forms
Autores:  Çelebier,Mustafa
Reçber,Tuba
Koçak,Engin
Altinöz,Sacide
Data:  2013-06-01
Ano:  2013
Palavras-chave:  HPLC
Rivaroxaban
Validation
System suitability
Stability-indicating
Pharmaceutical dosage form
Resumo:  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.
Tipo:  Info:eu-repo/semantics/article
Idioma:  Inglês
Identificador:  http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502013000200018
Editor:  Universidade de São Paulo, Faculdade de Ciências Farmacêuticas
Relação:  10.1590/S1984-82502013000200018
Formato:  text/html
Fonte:  Brazilian Journal of Pharmaceutical Sciences v.49 n.2 2013
Direitos:  info:eu-repo/semantics/openAccess
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