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Title: Development and Validation of Chromatographic methods for drugs i.e., Darifenacin, Zolpidem, Palonosetron and Intermediates to study the Impurity Profiles
Researcher: Murthy, M Vishnu
Guide(s): Ramesh kumar, N
Mukkanti, K
Keywords: Chromatographic
Upload Date: 9-Jun-2014
University: Jawaharlal Nehru Technological University, Hyderabad
Completed Date: 2013
Abstract: Determination of impurity profile for pharmaceutical compounds has a great importance while evaluating safety and efficacy of the drug product. In order to determine the impurity profiles, analytical testing of pharmaceutical compounds by means of suitable analytical techniques is newlinerequired. The thesis discusses the role of chromatographic techniques and need for the development of stability indicating analytical methods. The thesis also describes the current challenges in the chromatographic newlinemethod development and re-emphasizes the advantages of systematic method development approaches. Specific separation problems are newlineillustrated by selecting typical molecules that possess a variety of separation issues. The methodology further describes the way forward to resolve such separation problems. The method development activity newlinemainly focuses on the selection of suitable stationary phases and systematic optimization of chromatographic conditions. The specificity of the developed analytical methods is demonstrated by analyzing forced newlinedegradation samples and evaluating the spectral homogeneity of the compounds. In addition, possible degradation pathways are established based on LCMS analysis of the degradation impurities.
Pagination: 323 p.
Appears in Departments:Department of Chemistry

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01_title.pdfAttached File143.25 kBAdobe PDFView/Open
02_declaration.pdf176.82 kBAdobe PDFView/Open
03_certificate.pdf194.3 kBAdobe PDFView/Open
04_abstract.pdf145.99 kBAdobe PDFView/Open
05_acknowledgement.pdf235.28 kBAdobe PDFView/Open
06_contents.pdf426.93 kBAdobe PDFView/Open
07_list of tables & figures.pdf469.51 kBAdobe PDFView/Open
08_chapter 1.pdf1.01 MBAdobe PDFView/Open
09_chapter 2.pdf2.31 MBAdobe PDFView/Open
10_chapter 3.pdf1.29 MBAdobe PDFView/Open
11_chapter 4.pdf1.2 MBAdobe PDFView/Open
12_chapter 5.pdf2.29 MBAdobe PDFView/Open

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