![](/images/graphics-bg.png)
Development and Validation of Stability-Indicating GC-FID Method for the Quantitation of Memantine Hydrochloride and Its Nonchromophoric Impurities in Bulk and Pharmaceutical Dosages
Joint Authors
Bembalkar, Saroj R.
Jadhav, Sanjay A.
Landge, Shashikant B.
Niphade, Navanath C.
Mathad, Vijayavitthal T.
Source
Chromatography Research International
Issue
Vol. 2012, Issue 2012 (31 Dec. 2012), pp.1-10, 10 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2012-06-10
Country of Publication
Egypt
No. of Pages
10
Main Subjects
Abstract EN
A stability-indicating method has been developed and validated for the quantitative determination of memantine hydrochloride and its nonchromophoric impurities in drug substance and drug product using gas chromatography coupled with flame ionization detector (GC-FID).
The stability-indicating nature of the method has been proved by establishing peak purity and confirming the mass balance of all samples by subjecting them to stress conditions like hydrolysis, oxidation, photolysis, and thermal degradation studies.
The chromatographic separation was performed on a fused silica capillary (HP-5, 30 meter, 0.32 mm and 0.25 μm film thickness) column.
The method validation results indicate that the method has acceptable specificity, accuracy, linearity, precision, robustness, and high sensitivity with detection limits and quantitation limits ranging from 0.001% to 0.01% and 0.004% to 0.03%, respectively.
The effectiveness of the technique was demonstrated by analysis of different bulk sample of Memantine hydrochloride.
The proposed GC-FID method was also found to be specific and selective for the analysis of commercial formulation samples.
American Psychological Association (APA)
Jadhav, Sanjay A.& Landge, Shashikant B.& Niphade, Navanath C.& Bembalkar, Saroj R.& Mathad, Vijayavitthal T.. 2012. Development and Validation of Stability-Indicating GC-FID Method for the Quantitation of Memantine Hydrochloride and Its Nonchromophoric Impurities in Bulk and Pharmaceutical Dosages. Chromatography Research International،Vol. 2012, no. 2012, pp.1-10.
https://search.emarefa.net/detail/BIM-499521
Modern Language Association (MLA)
Jadhav, Sanjay A.…[et al.]. Development and Validation of Stability-Indicating GC-FID Method for the Quantitation of Memantine Hydrochloride and Its Nonchromophoric Impurities in Bulk and Pharmaceutical Dosages. Chromatography Research International No. 2012 (2012), pp.1-10.
https://search.emarefa.net/detail/BIM-499521
American Medical Association (AMA)
Jadhav, Sanjay A.& Landge, Shashikant B.& Niphade, Navanath C.& Bembalkar, Saroj R.& Mathad, Vijayavitthal T.. Development and Validation of Stability-Indicating GC-FID Method for the Quantitation of Memantine Hydrochloride and Its Nonchromophoric Impurities in Bulk and Pharmaceutical Dosages. Chromatography Research International. 2012. Vol. 2012, no. 2012, pp.1-10.
https://search.emarefa.net/detail/BIM-499521
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-499521