![](/images/graphics-bg.png)
A Stability-Indicating HPLC-DAD Method for Determination of Stiripentol: Development, Validation, Kinetics, Structure Elucidation and Application to Commercial Dosage Form
Joint Authors
Abdelhameed, Ali Saber
Darwish, Hany W.
Attia, Mohamed I.
Bakheit, Ahmed H.
Khalil, Nasr Y.
Al-Majed, Abdulrahman A.
Source
Journal of Analytical Methods in Chemistry
Issue
Vol. 2014, Issue 2014 (31 Dec. 2014), pp.1-10, 10 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2014-10-13
Country of Publication
Egypt
No. of Pages
10
Main Subjects
Abstract EN
A rapid, simple, sensitive, and accurate isocratic reversed-phase stability-indicating high performance liquid chromatography method has been developed and validated for the determination of stiripentol and its degradation product in its bulk form and pharmaceutical dosage form.
Chromatographic separation was achieved on a Symmetry C18 column and quantification was achieved using photodiode array detector (DAD).
The method was validated in accordance with the ICH requirements showing specificity, linearity (r2=0.9996, range of 1–25 μg/mL), precision (relative standard deviation lower than 2%), accuracy (mean recovery 100.08±1.73), limits of detection and quantitation (LOD = 0.024 and LOQ = 0.081 μg/mL), and robustness.
Stiripentol was subjected to various stress conditions and it has shown marked stability under alkaline hydrolytic stress conditions, thermal, oxidative, and photolytic conditions.
Stiripentol degraded only under acidic conditions, forming a single degradation product which was well resolved from the pure drug with significantly different retention time values.
This degradation product was characterized by 1H-NMR and 13C-NMR spectroscopy as well as ion trap mass spectrometry.
The results demonstrated that the method would have a great value when applied in quality control and stability studies for stiripentol.
American Psychological Association (APA)
Darwish, Hany W.& Abdelhameed, Ali Saber& Attia, Mohamed I.& Bakheit, Ahmed H.& Khalil, Nasr Y.& Al-Majed, Abdulrahman A.. 2014. A Stability-Indicating HPLC-DAD Method for Determination of Stiripentol: Development, Validation, Kinetics, Structure Elucidation and Application to Commercial Dosage Form. Journal of Analytical Methods in Chemistry،Vol. 2014, no. 2014, pp.1-10.
https://search.emarefa.net/detail/BIM-1039834
Modern Language Association (MLA)
Darwish, Hany W.…[et al.]. A Stability-Indicating HPLC-DAD Method for Determination of Stiripentol: Development, Validation, Kinetics, Structure Elucidation and Application to Commercial Dosage Form. Journal of Analytical Methods in Chemistry No. 2014 (2014), pp.1-10.
https://search.emarefa.net/detail/BIM-1039834
American Medical Association (AMA)
Darwish, Hany W.& Abdelhameed, Ali Saber& Attia, Mohamed I.& Bakheit, Ahmed H.& Khalil, Nasr Y.& Al-Majed, Abdulrahman A.. A Stability-Indicating HPLC-DAD Method for Determination of Stiripentol: Development, Validation, Kinetics, Structure Elucidation and Application to Commercial Dosage Form. Journal of Analytical Methods in Chemistry. 2014. Vol. 2014, no. 2014, pp.1-10.
https://search.emarefa.net/detail/BIM-1039834
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1039834