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Simultaneous determination of rivaroxaban and sitagliptin in rat plasma by LC–MS/MS and its application to pharmacokinetic drug-drug interaction study

Wang Libin, Shang Kun, Zhang Xiaorui, Zhang Xinying, Feng Tian, Xu Xiaohui, Wang Fang

Acta Chromatographica

2022

Vol. 34, no. 4

430--436

A sensitive and accurate LC-MS/MS method was developed and validated for the simultaneous quantification of rivaroxaban (RIV) and sitagliptin (SIT) in rat plasma using apixaban as internal standard (IS). An Agilent Eclipse plus C18 column (2.1 × 100 mm, 3.5 µm, Agilent) was used for chromatographic separation with isocratic elution. Multiple reaction monitoring (MRM) using positive-ion ESI mode to monitor ion transitions of m/z 436.8→144.9 for RIV, m/z 407.7→173.8 for SIT, m/z 459.8→442.8 for IS. The procedure of method validation included selectivity, linearity, precision, accuracy, matrix effect, extraction recovery and stability were conducted according to the guidelines of EMA and FDA. The results indicated that no obvious drug-drug interactions occurred might be owing to their differences in metabolic pathways.

Development of a stability-indicating HPLC method and a dissolution test for rivaroxaban dosage forms

Souri E., Mottaghi S., Zargarpoor M., Ahmadkhaniha R., Jalalizadeh H.

Acta Chromatographica

2016

Vol. 28, no. 3

347--361

Rivaroxaban is an inhibitor of factor Xa, which is used as an oral anticoagulant for the prevention of thromboembolism. The objective of this study was to develop a stability-indicating high-performance liquid chromatographic method for the quantitative determination of rivaroxaban in pharmaceutical dosage forms. Rivaroxaban was subjected to acidic, basic, oxidative, photolytic, and thermal conditions for forced stress degradation studies. Considerable degradation was observed in all stress degradation tests. Rivaroxaban and its degradation products were separated on a Nova-Pak C8 column utilizing a mixture of acetonitrile and KH2PO4 50 mM (pH 3.0) (40:60, v/v) as the mobile phase, and the chromatogram was recorded at 270 nm using a general ultraviolet (UV) detector. The developed method was linear over the concentration range of 1–50 μg mL−1 showing acceptable within-day and between-day precision and accuracy values (CV <2% and Error <2%). The dissolution profile of rivaroxaban tablets was also studied in the presence of a surfactant using optimized conditions. The validated method was successfully used for the determination of rivaroxaban in dosage forms and also in dissolution medium indicating the specificity of the assay method.

Nowe doustne leki przeciwzakrzepowe - wyzwanie dla laboratorium

Kozłowski P., Czyżewska E., Bobilewicz D.

Laboratorium - Przegląd Ogólnopolski

2014

nr 9-10

37--41

Problemy związane ze stosowaniem warfaryny były impulsem do poszukiwania leków bardziej bezpiecznych, które nie wymagałyby monitorowania w laboratorium. Dopuszczone do stosowania w Polsce trzy nowe doustne leki przeciwzakrzepowe należą do dwóch grup: bezpośrednich inhibitorów trombiny i czynnika Xa. Wprowadzenie tych leków na szeroką skalę stawia przed laboratoriami nowe wyzwania.

Problems associated with the usage of warfarin have led to the discovery of safer medicines, precluding the need for continuous laboratory monitoring. Three new drugs, belonging to two different groups: direct thrombin or factor Xa inhibitors, have been approved for use in Poland. The widespread use of these drugs has created new challenges for laboratory researchers.