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Title:Validacija HPLC metode za medfazno spremljavo sinteze (S)-1-[3-(Dimetilamino)propil]-1-(4-fluorofenil)-1,3-dihidro-5-izobenzofurankarbonitrila
Authors:ID Smolkovič, Bojan (Author)
ID Brodnjak-Vončina, Darinka (Mentor) More about this mentor... New window
ID Kolar, Mitja (Comentor)
ID Pečavar, Anica (Comentor)
Files:.pdf VS_Smolkovic_Bojan_2010.pdf (2,07 MB)
MD5: F3FC33703CF9BFB5BA28DF12B30BF650
PID: 20.500.12556/dkum/04825a45-e0ef-4577-9b51-3cd3bc1e2fe5
 
Language:Slovenian
Work type:Undergraduate thesis
Organization:FKKT - Faculty of Chemistry and Chemical Engineering
Abstract:Namen diplomskega dela je bil ovrednotiti in validirati HPLC medfazni analizni metodi za določevanje enantiomerne čistosti intermediata in kromatografske čistosti produkta pri medfazni spremljavi sinteze (S)-1-[3-(dimetilamino)propil]-1-(4-fluorofenil)-1,3-dihidro-5-izobenzofurankarbonitrila. Poudarek je bil na določitvi validacijskih parametrov, izdelavi validacijskega načrta, validacije, ovrednotenju rezultatov s statističnimi metodami in na interpretaciji rezultatov. Obe metodi sta natančni, točni, linearni, selektivni in robustni. Določene so bile meje zaznavanja, meje določanja in stabilnost raztopin za obe metodi. Metodi sta primerni za rutinsko določanje enantiomerne čistosti intermediata in kromatografske čistosti produkta pri medfazni spremljavi sinteze (S)-1-[3-(dimetilamino)propil]-1-(4-fluorofenil)-1,3-dihidro-5-izobenzofurankarbonitrila.
Keywords:dobra laboratorijska praksa, DLP, validacija, HPLC, intermediat, enantiomer, enantiomerna čistost, kromatografska čistost
Place of publishing:Maribor
Publisher:[B. Smolkovič]
Year of publishing:2010
PID:20.500.12556/DKUM-13906 New window
UDC:543.544.5(043.2)
COBISS.SI-ID:14263574 New window
NUK URN:URN:SI:UM:DK:VUTTIZWZ
Publication date in DKUM:25.05.2010
Views:3549
Downloads:309
Metadata:XML DC-XML DC-RDF
Categories:KTFMB - FKKT
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Secondary language

Language:English
Title:Validation of HPLC method for monitoring of in-process control during synthesis of (S)-1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile
Abstract:The purpose of diploma thesis was to validate and evaluate in-process HPLC methods for monitoring and determination of enantiomer purity of an intermediate substance and chromatographic purity of the product at synthesis of (S)-1-[3-(Dimethylamino)propyl]-1-(4- fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile. The main emphasis was to establish validation parameters, preparing validation plan, realization of validation, evaluation of validation results with statistical methods and interpretation of results. Both validated methods are precise, accurate, linear, selective and robust. Limit of detection, limit of quantitation and stability of standard and sample solutions were established. Methods are suitable for determination of enantiomer purity of intermediate substance and of chromatographic purity of the product at synthesis of (S)-1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro isobenzofuran-5-carbonitrile.
Keywords:good laboratory practice, GLP, validation, HPLC, intermediate substance, enantiomer, enantiomer purity, chomatographic purity


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