Evaluation of the stability of gentamicin in different antibiotic carriers using a validated MEKC method.
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.
Kühn
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Heraeus Medical GmbH, Philipp-Reis-Str. 8/13, 61273 Wehrheim, Germany.
Weber
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Kreis
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Holzgrabe
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D000900:Anti-Bacterial Agents / Q000032:analysis* / Q000737:chemistry; D001881:Borates / Q000737:chemistry; D020374:Chromatography, Micellar Electrokinetic Capillary / Q000379:methods*; D003840:Deoxycholic Acid / Q000737:chemistry; D016503:Drug Delivery Systems; D004355:Drug Stability; D005839:Gentamicins / Q000032:analysis* / Q000737:chemistry; D006863:Hydrogen-Ion Concentration; D015394:Molecular Structure; D011786:Quality Control; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D047392:beta-Cyclodextrins / Q000737:chemistry
D000900:Anti-Bacterial Agents; D001881:Borates; D005839:Gentamicins; D047392:beta-Cyclodextrins; D003840:Deoxycholic Acid; C031215:betadex