development and validation of stability-indicating gc-fid method for the quantitation of memantine hydrochloride and its nonchromophoric impurities in bulk and pharmaceutical dosages英文论文.pdfVIP

Hindawi Publishing Corporation Chromatography Research International Volume 2012, Article ID 806068, 10 pages doi:10.1155/2012/806068 Research Article Development and Validation of Stability-Indicating GC-FID Method for the Quantitation of Memantine Hydrochloride and Its Nonchromophoric Impurities in Bulk and Pharmaceutical Dosages Sanjay A. Jadhav,1 Shashikant B. Landge,1 Navanath C. Niphade,1 Saroj R. Bembalkar,2 and Vijayavitthal T. Mathad1 1 Research and Development, Megafine Pharma (P) Ltd., Nashik 422 202, India 2 Department of Chemistry, Deogiri College, Aurangabad 431004, India Correspondence should be addressed to Vijayavitthal T. Mathad, drvtmathad@yahoo.co.in Received 5 January 2012; Revised 18 March 2012; Accepted 11 April 2012 Academic Editor: Meehir Palit Copyright © 2012 Sanjay A. Jadhav et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 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,