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

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 o 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 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.Uniterms: HPLC. Rivaroxaban. Validation. System suitability. Stability-indicating. Pharmaceutical dosage form.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 o C. 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.Unitermos: HPLC. Rivaroxabana. Validação. Adequação do sistema. Indicador de estabilidade. Forma farmacêutica.

Ecofriendly densitometric RP-HPTLC method for determination of rivaroxaban in nanoparticle formulations using green solvents

“…5 In the literature, many "high-performance liquid chromatography (HPLC)" methods are available for the quantication of rivaroxaban in its dosage forms especially tablet dosage forms. 3,[6][7][8][9][10][11][12][13][14][15][16][17][18][19] Some HPLC methods are also available for the analysis of rivaroxaban in human or rat plasma. 6,20 Some "high-performance thin layer chromatography (HPTLC)" 3,11,21 and spectrophotometric methods 11,22,23 have also been proposed for the analysis of rivaroxaban in its tablet formulations.…”

Physical Stability of Rivaroxaban Loaded Liposomes Coated with Low Molecular Weight Chitosan

“…The data in table (5) and the charts in figures (4)(5), demonstrate the effect of storage on the ZP and the EE% of the selected formulations. As the data shows, the selected formulations were generally stable on storage and no prominent change was observed on the mentioned two parameters.…”

Spectrophotometric quantification of direct factor xa inhibitor, rivaroxaban, in raw and tablet dosage form

“…They include factor Xa specific chromogenic substrate assay [7], anti-Factor Xa chromogenic assay [8][9][10], prothrombin time assay [11], HPLC-MS/MS [12][13][14], HPTLC [15,16], HPLC [16][17][18][19][20][21][22][23][24][25][26] and UPLC [27]. The above reported methods suffer from drawbacks such as time consuming, cum bersome procedure, costly and require an expertise operational personal .…”