دورية أكاديمية
Quantitative Assessment of Poorly Soluble Anticoagulant Rivaroxaban by Microemulsion Electrokinetic Chromatography.
العنوان: | Quantitative Assessment of Poorly Soluble Anticoagulant Rivaroxaban by Microemulsion Electrokinetic Chromatography. |
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المؤلفون: | Wingert NR; Laboratório de Controle de Qualidade Farmacêutico, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul (UFRGS), Av. Ipiranga, lab 402, Porto Alegre, Brazil., Dos Santos NO; Laboratório de Controle de Qualidade Farmacêutico, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul (UFRGS), Av. Ipiranga, lab 402, Porto Alegre, Brazil., Campanharo SC; Laboratório de Controle de Qualidade Farmacêutico, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul (UFRGS), Av. Ipiranga, lab 402, Porto Alegre, Brazil., Jablonski A; Engenharia de Minas, UFRGS, Av. Bento Gonçalves, Building 74, Porto Alegre, Brazil., Steppe M; Laboratório de Controle de Qualidade Farmacêutico, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul (UFRGS), Av. Ipiranga, lab 402, Porto Alegre, Brazil. |
المصدر: | Journal of chromatographic science [J Chromatogr Sci] 2018 Aug 01; Vol. 56 (7), pp. 650-655. |
نوع المنشور: | Journal Article |
اللغة: | English |
بيانات الدورية: | Publisher: Oxford University Press Country of Publication: United States NLM ID: 0173225 Publication Model: Print Cited Medium: Internet ISSN: 1945-239X (Electronic) Linking ISSN: 00219665 NLM ISO Abbreviation: J Chromatogr Sci Subsets: MEDLINE |
أسماء مطبوعة: | Publication: <2012- > : Oxford : Oxford University Press Original Publication: Niles Il : Preston Technical Abstracts |
مواضيع طبية MeSH: | Anticoagulants/*analysis , Chromatography, Micellar Electrokinetic Capillary/*methods , Rivaroxaban/*analysis, Drug Stability ; Limit of Detection ; Linear Models ; Reproducibility of Results |
مستخلص: | Microemulsion electrokinetic chromatography (MEEKC) is an electrophoretic methodology based on the separation of compounds by a microemulsionated electrolyte. There are few options for the evaluation of the stability and content of the oral anticoagulant rivaroxaban (RIV) in pharmaceutical formulations. RIV has low water solubility and undergoes ionization only under restricted pH conditions (pH < 1 or pH > 13), thus, hindering the application of free zone capillary electrophoresis as an analytical method. Therefore, the work aimed at developing and validating a stability-indicating MEEKC method for the analysis of RIV in pharmaceutical formulations. Separation was performed in a fused-silica capillary applying a voltage of 30 kV. The microemulsion system consisted of 13 mM tetraborate, pH 9.75 + 1.2% SDS + 1.0% ethyl acetate + 2.4% butanol. The linearity range was 25-150 μg mL-1, with r = 0.9982. Drug degradations were performed in acid and basic media (HCl 1 M and NaOH 0.1 M, respectively), oxidation with 3%H2O2, 60°C temperature and exposure to UV-C radiation. No interferences with RIV or internal standard peaks were detected. Method robustness was accessed through Plackett-Burman experimental design, after evaluation of model validity. Trueness values between 100.49 and 100.68% were obtained with repeatability. The method developed was found appropriate for quality control of RIV tablets, as a consistent analytical technique that is considered less damaging to the environment due to its low consumption of organic reagents. |
المشرفين على المادة: | 0 (Anticoagulants) 9NDF7JZ4M3 (Rivaroxaban) |
تواريخ الأحداث: | Date Created: 20180619 Date Completed: 20180801 Latest Revision: 20180801 |
رمز التحديث: | 20221213 |
DOI: | 10.1093/chromsci/bmy036 |
PMID: | 29912345 |
قاعدة البيانات: | MEDLINE |
تدمد: | 1945-239X |
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DOI: | 10.1093/chromsci/bmy036 |