دورية أكاديمية
أعرض في EDS

Development of a stability indicating high-performance liquid chromatography method for determination of cenobamate: study of basic degradation kinetics.

التفاصيل البيبلوغرافية
العنوان: Development of a stability indicating high-performance liquid chromatography method for determination of cenobamate: study of basic degradation kinetics.
المؤلفون: El-Malla SF; 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., Elagamy SH; Department of pharmaceutical analytical chemistry, Faculty of pharmacy, Tanta University, Tanta, Egypt. samar.elagamy@pharm.tanta.edu.eg.
المصدر: BMC chemistry [BMC Chem] 2024 Apr 13; Vol. 18 (1), pp. 74. Date of Electronic Publication: 2024 Apr 13.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Springer Nature Country of Publication: Switzerland NLM ID: 101741142 Publication Model: Electronic Cited Medium: Internet ISSN: 2661-801X (Electronic) Linking ISSN: 2661801X NLM ISO Abbreviation: BMC Chem Subsets: PubMed not MEDLINE
أسماء مطبوعة: Original Publication: Cham, Switzerland : Springer Nature, [2019]-
مستخلص: This study presents a stability indicating high-performance liquid chromatography HPLC method for the determination of cenobamate (CNB) in presence of its main impurity (CNB H-impurity) and degradation products. The chromatographic separation was carried out on a Thermo BDS Hypersil-C18 column (150 × 4.6 mm; 5 μm) with a mobile phase consisting of a 50:50 (%v/v) ratio of methanol and purified water. The flow rate was maintained at 1.0 mL. min - 1 . CNB was detected at 210 nm using a PDA detector. The column temperature was held at 40 °C.The retention time of the drug was found to be 3.2 min. Furthermore, the study investigates the degradation behavior of CNB under various stress conditions, including acidic, basic, oxidative, and light-induced degradation. The results indicate that CNB is particularly susceptible to basic degradation. Consequently, a comprehensive study of the basic degradation kinetics was conducted. The method was also successfully applied for the determination of CNB in its dosage form. The results also show that there is no co-elution from degradation products or excipients as indicated by the mass balance and peak purity values confirming the specificity of the proposed method and its applicability for routine analysis of CNB.
(© 2024. The Author(s).)
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فهرسة مساهمة: Keywords: Cenobamate; Impurity; Stress degradation, kinetics
تواريخ الأحداث: Date Created: 20240413 Latest Revision: 20240425
رمز التحديث: 20240425
مُعرف محوري في PubMed: PMC11016219
DOI: 10.1186/s13065-024-01177-4
PMID: 38615027
قاعدة البيانات: MEDLINE
الوصف
تدمد:2661-801X
DOI:10.1186/s13065-024-01177-4