Please use this identifier to cite or link to this item: http://hdl.handle.net/10603/590112
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dc.date.accessioned2024-09-19T06:54:50Z-
dc.date.available2024-09-19T06:54:50Z-
dc.identifier.urihttp://hdl.handle.net/10603/590112-
dc.description.abstractForced degradation studies under rigorous conditions should be conceded on drug to find out the inherent strength character also degradation pathway to maintain the correctness of the planned analytical procedures. Further, the identification of degradants in pharmaceuticals is critically important for reasons of both product efficacy and patient safety. There are no reports for the identification of degradants by chromatographic techniques for the recent CNS drugs viz Ezogabine and Zolpidem tartrate. Complete LC plus LCMS method of degradation behavior on these CNS drugs under different ICH prescribed stress conditions have also be deficient. Ezogabine or retigabine (RTG) chemically called as N-(2-amino-4-(4-fluorobenzylamino) phenyl) carbamic acid ethyl ester. The drug is a new anti-epileptic drug and the drug is not official in IP, BP and USP. The drug is a colorless and freely soluble in polar solvents. Zolpidem tartrate (ZOL), chemically called as N, N-dimethyl-2-[6-methyl-2-(4-methylphenyl) imidazo [1, 2-a] pyridin-3-yl] acetamide L (+) tartrate. The drug is used as hypnotic. The drug is a colorless crystalline powder and sparingly soluble in alcohol plus water. Zolpidem tartrate is official in IP20 (2014) and USP20 (2011). IMPACT OF THE STUDY: Developed and validated a stability indicating RP-HPLC method for the determination of selected CNS drugs like Ezogabine in bulk form and Zolpidem tartrate present in tablet dosage form. To assess stability profile of these drug /drug products during manufacturing, processing, storage conditions and safety. Forced degradation studies were carried out for the selected CNS drugs like Ezogabine and Zolpidem tartrate. Degradation product of ezogabine and zolpidem tartrate were separated by preparative HPLC method and identified by IR, NMR and mass spectral data. Degradation product of ezogabine and zolpidem tartrate were used for the determination of mutagenicity and found non mutagenic by Ames test. Full mass accountability of the degradation products was obtained.
dc.format.extent263
dc.languageEnglish
dc.relation
dc.rightsuniversity
dc.titleForced Degradation studies of CNS Drugs and Identification of Possible Degradants by Chromatographic Techniques
dc.title.alternative
dc.creator.researcherTamilselvi N
dc.subject.keywordChromatographic Techniques
dc.subject.keywordCNS Drugs
dc.subject.keywordEzogabine
dc.subject.keywordForced Degradation studies
dc.subject.keywordIdentification
dc.subject.keywordPossible Degradants
dc.subject.keywordZolpidem tartrate
dc.description.note
dc.contributor.guideRajasekaran A
dc.publisher.placeChennai
dc.publisher.universityThe Tamil Nadu Dr. M.G.R. Medical University
dc.publisher.institutionDepartment of Pharmacy
dc.date.registered2012
dc.date.completed2016
dc.date.awarded2018
dc.format.dimensions
dc.format.accompanyingmaterialNone
dc.source.universityUniversity
dc.type.degreePh.D.
Appears in Departments:Department of Pharmacy

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01_title.pdfAttached File131.03 kBAdobe PDFView/Open
02_prelim pages.pdf10.43 MBAdobe PDFView/Open
03_content.pdf1.82 MBAdobe PDFView/Open
05_chapter 1.pdf2.97 MBAdobe PDFView/Open
06_chapter 2.pdf1.29 MBAdobe PDFView/Open
07_chapter 3.pdf9.04 MBAdobe PDFView/Open
08_chapter 4.pdf1.11 MBAdobe PDFView/Open
09_chapter 5.pdf20.76 MBAdobe PDFView/Open
10_annexures.pdf18.42 MBAdobe PDFView/Open
10_chapter 6.pdf28.54 MBAdobe PDFView/Open
11_chapter 7.pdf4.21 MBAdobe PDFView/Open
80_recommendation.pdf2.89 MBAdobe PDFView/Open


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