CHEMICAL STABILITY OF CEFTRIAXONE BY A VALIDATED STABILITY-INDICATING LIQUID CHROMATOGRAPHIC METHOD

The chemical stability of ceftriaxone for injection reconstituted with water was studied at different storage conditions by a validated stability-indicating ion-pair liquid chromatographic method. The study was performed on ceftriaxone for injection samples obtained from two pharmaceutical laborator...

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Autores principales: DE DIEGO,M, GODOY,G, MENNICKENT,S
Lenguaje:English
Publicado: Sociedad Chilena de Química 2010
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Acceso en línea:http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072010000300013
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spelling oai:scielo:S0717-970720100003000132011-01-25CHEMICAL STABILITY OF CEFTRIAXONE BY A VALIDATED STABILITY-INDICATING LIQUID CHROMATOGRAPHIC METHODDE DIEGO,MGODOY,GMENNICKENT,S Stability ion-pair liquid chromatography ceftriaxone The chemical stability of ceftriaxone for injection reconstituted with water was studied at different storage conditions by a validated stability-indicating ion-pair liquid chromatographic method. The study was performed on ceftriaxone for injection samples obtained from two pharmaceutical laboratories, at three different temperatures: 23 °C ± 2 °C, + 8 °C ± 1 °C and - 20 °C ± 0.5 °C, over 26 days, 55 days, and 76 days, respectively. Chromatographic separation was achieved on a RP-18 column, using a mobile phase consisting of 250 mL acetonitrile, 50 mL phosphate buffer (pH 7.4; 0.1M), 3.2 g tetrabutylammonium bromide made up to a volume of 1 L with water, at a flow rate of 1.0 mL min-1 and UV detection at 260 nm. The stability-indicating capability of the assay was estabhshed by forced degradation studies under hydrolysis, high temperature and photolysis. The developed method was specific, stability indicating, accurate and precise for ceftriaxone determination. At room temperature and at + 8 °C the degradation of ceftriaxone followed first-order kinetics and the samples were chemically stable for at least 4 and 41 days respectively. At - 20 °C the concentration of all samples remained higher than 90% of the original concentration. Degradation of ceftriaxone was higher at room temperature; therefore lower storage temperatures improved the chemical stability of ceftriaxone for injection in water.info:eu-repo/semantics/openAccessSociedad Chilena de QuímicaJournal of the Chilean Chemical Society v.55 n.3 20102010-01-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072010000300013en10.4067/S0717-97072010000300013
institution Scielo Chile
collection Scielo Chile
language English
topic Stability
ion-pair liquid chromatography
ceftriaxone
spellingShingle Stability
ion-pair liquid chromatography
ceftriaxone
DE DIEGO,M
GODOY,G
MENNICKENT,S
CHEMICAL STABILITY OF CEFTRIAXONE BY A VALIDATED STABILITY-INDICATING LIQUID CHROMATOGRAPHIC METHOD
description The chemical stability of ceftriaxone for injection reconstituted with water was studied at different storage conditions by a validated stability-indicating ion-pair liquid chromatographic method. The study was performed on ceftriaxone for injection samples obtained from two pharmaceutical laboratories, at three different temperatures: 23 °C ± 2 °C, + 8 °C ± 1 °C and - 20 °C ± 0.5 °C, over 26 days, 55 days, and 76 days, respectively. Chromatographic separation was achieved on a RP-18 column, using a mobile phase consisting of 250 mL acetonitrile, 50 mL phosphate buffer (pH 7.4; 0.1M), 3.2 g tetrabutylammonium bromide made up to a volume of 1 L with water, at a flow rate of 1.0 mL min-1 and UV detection at 260 nm. The stability-indicating capability of the assay was estabhshed by forced degradation studies under hydrolysis, high temperature and photolysis. The developed method was specific, stability indicating, accurate and precise for ceftriaxone determination. At room temperature and at + 8 °C the degradation of ceftriaxone followed first-order kinetics and the samples were chemically stable for at least 4 and 41 days respectively. At - 20 °C the concentration of all samples remained higher than 90% of the original concentration. Degradation of ceftriaxone was higher at room temperature; therefore lower storage temperatures improved the chemical stability of ceftriaxone for injection in water.
author DE DIEGO,M
GODOY,G
MENNICKENT,S
author_facet DE DIEGO,M
GODOY,G
MENNICKENT,S
author_sort DE DIEGO,M
title CHEMICAL STABILITY OF CEFTRIAXONE BY A VALIDATED STABILITY-INDICATING LIQUID CHROMATOGRAPHIC METHOD
title_short CHEMICAL STABILITY OF CEFTRIAXONE BY A VALIDATED STABILITY-INDICATING LIQUID CHROMATOGRAPHIC METHOD
title_full CHEMICAL STABILITY OF CEFTRIAXONE BY A VALIDATED STABILITY-INDICATING LIQUID CHROMATOGRAPHIC METHOD
title_fullStr CHEMICAL STABILITY OF CEFTRIAXONE BY A VALIDATED STABILITY-INDICATING LIQUID CHROMATOGRAPHIC METHOD
title_full_unstemmed CHEMICAL STABILITY OF CEFTRIAXONE BY A VALIDATED STABILITY-INDICATING LIQUID CHROMATOGRAPHIC METHOD
title_sort chemical stability of ceftriaxone by a validated stability-indicating liquid chromatographic method
publisher Sociedad Chilena de Química
publishDate 2010
url http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072010000300013
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AT godoyg chemicalstabilityofceftriaxonebyavalidatedstabilityindicatingliquidchromatographicmethod
AT mennickents chemicalstabilityofceftriaxonebyavalidatedstabilityindicatingliquidchromatographicmethod
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