دورية أكاديمية

Development of stability indicating reversed-phase high-performance liquid chromatography method for determination of elobixibat in pure form and laboratory prepared tablets: Application to dissolution study.

التفاصيل البيبلوغرافية
العنوان: Development of stability indicating reversed-phase high-performance liquid chromatography method for determination of elobixibat in pure form and laboratory prepared tablets: Application to dissolution study.
المؤلفون: Elagamy SH; Department of pharmaceutical analytical chemistry, Faculty of Pharmacy, Tanta University, Tanta, Egypt., Mansour FR; Department of pharmaceutical analytical chemistry, Faculty of Pharmacy, Tanta University, Tanta, Egypt., Elbastawissy ABB; Department of pharmaceutical analytical chemistry, Faculty of Pharmacy, Tanta University, Tanta, Egypt., El-Malla SF; Department of pharmaceutical analytical chemistry, Faculty of Pharmacy, Tanta University, Tanta, Egypt.
المصدر: Journal of separation science [J Sep Sci] 2022 Sep; Vol. 45 (18), pp. 3529-3541. Date of Electronic Publication: 2022 Aug 07.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Wiley-VCH Country of Publication: Germany NLM ID: 101088554 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1615-9314 (Electronic) Linking ISSN: 16159306 NLM ISO Abbreviation: J Sep Sci Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Weinheim, Germany : Wiley-VCH, c2001-
مواضيع طبية MeSH: Excipients* , Silicon Dioxide*, Acetonitriles ; Chromatography, High Pressure Liquid/methods ; Dipeptides ; Drug Stability ; Phosphates ; Reproducibility of Results ; Solubility ; Tablets ; Thiazepines
مستخلص: A simple stability-indicating reversed-phase high-performance liquid chromatography method has been developed for determination of elobixibat in presence of its potential impurities and degradation products. The chromatographic separation was carried on a Thermo scientific Base Deactivated Silica BDS Hypersil-C18 (150 × 4.6 mm; 5 μm) column using a mobile phase of acetonitrile and phosphate buffer (25 mM, pH 2.5) in a ratio of (70:30, v/v). The experimental conditions were accurately investigated, and the method was validated according to ICH guidelines Q2 (R1). The drug was subjected to various stress conditions including acidic, basic, oxidative, and photolytic conditions. The method successfully separates the drug from the three reported impurities and different degradants. The method was also successfully applied for the determination of elobixibat in laboratory prepared tablets (5.0 mg). Analysis shows no interference from excipients and degradation products. The method was also applied for performing in vitro dissolution testing of elobixibat laboratory prepared tablets. Since elobixibat is recently introduced into the market, there are no previous stability studies and no reported analytical methods for its determination. Thus, this study presents a validated and selective method that can be effectively employed in routine quality control studies.
(© 2022 Wiley-VCH GmbH.)
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فهرسة مساهمة: Keywords: elobixibat; in vitro dissolution testing; stability indicating assay method; stress degradation
المشرفين على المادة: 0 (Acetonitriles)
0 (Dipeptides)
0 (Excipients)
0 (Phosphates)
0 (Tablets)
0 (Thiazepines)
7631-86-9 (Silicon Dioxide)
865UEK4EJC (elobixibat)
تواريخ الأحداث: Date Created: 20220727 Date Completed: 20220929 Latest Revision: 20220929
رمز التحديث: 20240628
DOI: 10.1002/jssc.202200322
PMID: 35894696
قاعدة البيانات: MEDLINE