Document Detail


Evaluation of the stability of gentamicin in different antibiotic carriers using a validated MEKC method.
MedLine Citation:
PMID:  18639995     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The quality control of gentamicin in different antibiotic carriers, using MEKC as stability-indicating method is described. Baseline separations of gentamicin C1, C1a, C2, C2a and C2b and, furthermore the impurities and degradation products garamin (GARA), 2-deoxy-streptamine (DSA) and sisomicin (SISO) were achieved with a background electrolyte containing 20mM deoxycholic acid, 15 mM beta-cyclodextrin and 100mM tetraborate (pH 10.0). After derivatization with o-phthaldialdehyde reagent (OPA), UV detection at 340 nm was possible. The method was validated with respect to selectivity, limit of detection (LOD) and quantification (LOQ) of the impurities, linearity, accuracy, precision and robustness. Evaluation of four different antibiotic carriers stored under stability conditions according to the International Conference on Harmonization (ICH) guidelines and older pharmaceutical formulations disclosed good stability.
Authors:
K-D Kühn; C Weber; S Kreis; U Holzgrabe
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Publication Detail:
Type:  Evaluation Studies; Journal Article     Date:  2008-06-18
Journal Detail:
Title:  Journal of pharmaceutical and biomedical analysis     Volume:  48     ISSN:  0731-7085     ISO Abbreviation:  J Pharm Biomed Anal     Publication Date:  2008 Nov 
Date Detail:
Created Date:  2008-10-20     Completed Date:  2009-02-26     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8309336     Medline TA:  J Pharm Biomed Anal     Country:  England    
Other Details:
Languages:  eng     Pagination:  612-8     Citation Subset:  IM    
Affiliation:
Heraeus Medical GmbH, Philipp-Reis-Str. 8/13, 61273 Wehrheim, Germany.
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MeSH Terms
Descriptor/Qualifier:
Anti-Bacterial Agents / analysis*,  chemistry
Borates / chemistry
Chromatography, Micellar Electrokinetic Capillary / methods*
Deoxycholic Acid / chemistry
Drug Delivery Systems*
Drug Stability
Gentamicins / analysis*,  chemistry
Hydrogen-Ion Concentration
Molecular Structure
Quality Control
Reproducibility of Results
Sensitivity and Specificity
beta-Cyclodextrins / chemistry
Chemical
Reg. No./Substance:
0/Anti-Bacterial Agents; 0/Borates; 0/Gentamicins; 0/beta-Cyclodextrins; 7585-39-9/betadex; 83-44-3/Deoxycholic Acid

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


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