Mostrar el registro sencillo del ítem

dc.contributor.author
Teglia, Carla Mariela
dc.contributor.author
Montemurro, Milagros
dc.contributor.author
de Zan, María Mercedes
dc.contributor.author
Cámara, María Silvia
dc.date.available
2018-05-03T19:49:58Z
dc.date.issued
2015-10
dc.identifier.citation
Teglia, Carla Mariela; Montemurro, Milagros; de Zan, María Mercedes; Cámara, María Silvia; Multiple responses optimization in the development of a headspace gas chromatography method for the determination of residual solvents in pharmaceuticals; Elsevier; Journal of Pharmaceutical Analysis; 5; 5; 10-2015; 296-306
dc.identifier.issn
2095-1779
dc.identifier.uri
http://hdl.handle.net/11336/44041
dc.description.abstract
An efficient generic static headspace gas chromatography (HSGC) method was developed, optimized and validated for the routine determination of several residual solvents (RS) in drug substance, using a strategy with two sets of calibration. Dimethylsulfoxide (DMSO) was selected as the sample diluent and internal standards were used to minimize signal variations due to the preparative step. A gas chromatograph from Agilent Model 6890 equipped with flame ionization detector (FID) and a DB?624 (30 m x 0.53 mm i.d., 3.00 µm film thickness) column was used. The inlet split ratio was 5:1. The influencing factors in the chromatographic separation of the analytes were determined through a fractional factorial experimental design. Significant variables: the initial temperature (IT), the final temperature (FT) of the oven and the carrier gas flow rate (F) were optimized using a central composite design. Response transformation and desirability function were applied to find out the optimal combination of the chromatographic variables to achieve an adequate resolution of the analytes and short analysis time. These conditions were: 30ºC for IT, 158ºC for FT and 1.90 mL/min for F. The method was proven to be accurate, linear in a wide range and very sensitive for the analyzed solvents, through a comprehensive validation made according ICH guidelines.
dc.format
application/pdf
dc.language.iso
eng
dc.publisher
Elsevier
dc.rights
info:eu-repo/semantics/openAccess
dc.rights.uri
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
dc.subject
Residuals
dc.subject
Solvents
dc.subject
Pharmaceuticals
dc.subject.classification
Otras Ciencias Químicas
dc.subject.classification
Ciencias Químicas
dc.subject.classification
CIENCIAS NATURALES Y EXACTAS
dc.title
Multiple responses optimization in the development of a headspace gas chromatography method for the determination of residual solvents in pharmaceuticals
dc.type
info:eu-repo/semantics/article
dc.type
info:ar-repo/semantics/artículo
dc.type
info:eu-repo/semantics/publishedVersion
dc.date.updated
2018-04-27T20:26:48Z
dc.journal.volume
5
dc.journal.number
5
dc.journal.pagination
296-306
dc.journal.pais
Países Bajos
dc.journal.ciudad
Amsterdam
dc.description.fil
Fil: Teglia, Carla Mariela. Universidad Nacional del Litoral. Facultad de Bioquímica y Ciencias Biológicas. Departamento de Química. Cátedra de Química Analítica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Santa Fe; Argentina
dc.description.fil
Fil: Montemurro, Milagros. Universidad Nacional del Litoral. Facultad de Bioquímica y Ciencias Biológicas. Departamento de Química. Cátedra de Química Analítica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Santa Fe; Argentina
dc.description.fil
Fil: de Zan, María Mercedes. Universidad Nacional del Litoral. Facultad de Bioquímica y Ciencias Biológicas. Departamento de Química. Cátedra de Química Analítica; Argentina
dc.description.fil
Fil: Cámara, María Silvia. Universidad Nacional del Litoral. Facultad de Bioquímica y Ciencias Biológicas. Departamento de Química. Cátedra de Química Analítica; Argentina
dc.journal.title
Journal of Pharmaceutical Analysis
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/doi/http://dx.doi.org/10.1016/j.jpha.2015.02.004
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/pii/S2095177915000325


Archivos asociados

 

Comunidades y colecciones

Mostrar el registro sencillo del ítem