| Journal: | Brazilian journal of pharmaceutical sciences |
| Database: | PERIÓDICA |
| System number: | 000363712 |
| ISSN: | 1984-8250 |
| Authors: | Celebier, Mustafa1 Recber, Tuba1 Kocak, Engin1 Altinoz, Sacide1 |
| Institutions: | 1Hacettepe University, Faculty of Pharmacy, Ankara. Turquía |
| Year: | 2013 |
| Season: | Abr-Jun |
| Volumen: | 49 |
| Number: | 2 |
| Pages: | 359-366 |
| Country: | Brasil |
| Language: | Inglés |
| Document type: | Artículo |
| Approach: | Experimental, analítico |
| English 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® (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 |
| Portuguese abstract | Rivaroxabana, fármaco anticoagulante, atua em um ponto crucial no processo de coagulação do sangue e impede a formação de coágulos sanguíneos. Neste estudo, desenvolveu-se método de RP-HPLC para a determinação de rivaroxabana em comprimidos (Xarelto ® (10 mg)). Utilizou-se coluna LC (250 x 4,6 mm) Phenomenex Luna C18 5 mm 100 Å a 40 oC. Realizou-se eluição isocrática com ACN: água (55:45 v/v). O fluxo foi de 1,2 mL min-1 e a detecção de UV foi a 249 nm. Padrão interno (cafeína) e rivaroxabana eluíram em 2,21 e 3,37 minutos, respectivamente. O método desenvolvido foi validado de acordo com as diretrizes do ICH e mostrou-se linear na faixa 0,005-40,0 mg mL-1. O método foi exato, preciso, robusto e rápido. Assim, foi aplicado com êxito para o ensaio de controle de qualidade da Rivaroxabana na forma de comprimidos |
| Disciplines: | Química |
| Keyword: | Química farmacéutica, Rivaroxabán, HPLC, Validación, Estabilidad química |
| Keyword: | Chemistry, Medicinal chemistry, Rivaroxaban, HPLC, Validation, Chemical stability |
| Full text: | Texto completo (Ver HTML) |
