Document Detail


Ion-pairing high-performance liquid chromatographic method for the determination of 5-aminosalicylic acid and related impurities in bulk chemical.
MedLine Citation:
PMID:  1818083     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
An ion-pairing high-performance liquid chromatographic method has been developed for the determination of 5-aminosalicylic acid (5-ASA) bulk chemical in the presence of thirteen potential synthetic process impurities. In addition, the method is suitable for the determination of the in process intermediate, 5-nitrosalicylic acid. A selective method was achieved on a Hypersil-BDS reversed-phase column using 1-heptanesulfonic acid sodium salt as the ion-pairing reagent in a 0.08 M sodium phosphate buffer (pH 2) containing 0.005 M 1-heptanesulfonic acid sodium salt and 0.07 M sodium chloride-methanol-tetrahydrofuran (85:11:4, v/v/v) isocratic mobile phase. The method was validated using a multi-day, intra-laboratory protocol. The validation addressed linearity, accuracy, precision, sensitivity, and ruggedness of the method. The validated method characterizes the purity of 5-ASA bulk chemical.
Authors:
B S Kersten; T Catalano; Y Rozenman
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of chromatography     Volume:  588     ISSN:  -     ISO Abbreviation:  J. Chromatogr.     Publication Date:  1991 Dec 
Date Detail:
Created Date:  1992-07-13     Completed Date:  1992-07-13     Revised Date:  2013-12-13    
Medline Journal Info:
Nlm Unique ID:  0427043     Medline TA:  J Chromatogr     Country:  NETHERLANDS    
Other Details:
Languages:  eng     Pagination:  187-93     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Aminosalicylic Acids / analysis*
Chromatography, High Pressure Liquid / methods*,  standards,  statistics & numerical data
Drug Contamination*
Mesalamine
Quality Control
Chemical
Reg. No./Substance:
0/Aminosalicylic Acids; 4Q81I59GXC/Mesalamine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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