A Validated Specific Stability-Indicating RP-HPLC Assay Method for the Determination of Loteprednol Etabonate in Eye Drops

Autores
Han, Yong Ki; Segall, Adriana Ines
Año de publicación
2014
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
A new stability-indicating RP-HPLC assay method was developed and validated for quantitative determination of loteprednol etabonate in bulk drugs and in ophthalmic suspensions in the presence of degradation products generated from forced degradation studies. The system consisted of Agilent Technologies Zorbax Eclipse XDB-Phenyl 5 µm 4.6 × 250 mm, and detection was performed at 244 nm. The mobile phase consisted of water–acetonitrile–acetic acid (34.5:65.0:0.5, v/v/v) run at a flow rate of 1 mL/min and maintained at room temperature. The calibration curve was linear from 30 to 70 µg/mL with r > 0.999. Accuracy (mean recovery 100.78%) and precision were found to be satisfactory. Stress conditions including acid and alkali hydrolysis, water stress, oxidation, photolysis and heat were applied. The degradation products did not interfere with the detection of loteprednol etabonate, thus the method can be considered as a stability-indicating method. The proposed method can be used for quality control assay of loteprednol etabonate in bulk drug and in ophthalmic suspensions and for stability studies as a result of the ability of the method to separate loteprednol etabonate from its degradation products and excipients.
Fil: Han, Yong Ki. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentina
Fil: Segall, Adriana Ines. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentina
Materia
Loteprednol Etabonate
Stability Indicating
Validation
Hplc
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/30541
Acceder
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oai_identifier_str oai:ri.conicet.gov.ar:11336/30541
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling A Validated Specific Stability-Indicating RP-HPLC Assay Method for the Determination of Loteprednol Etabonate in Eye DropsHan, Yong KiSegall, Adriana InesLoteprednol EtabonateStability IndicatingValidationHplchttps://purl.org/becyt/ford/1.4https://purl.org/becyt/ford/1A new stability-indicating RP-HPLC assay method was developed and validated for quantitative determination of loteprednol etabonate in bulk drugs and in ophthalmic suspensions in the presence of degradation products generated from forced degradation studies. The system consisted of Agilent Technologies Zorbax Eclipse XDB-Phenyl 5 µm 4.6 × 250 mm, and detection was performed at 244 nm. The mobile phase consisted of water–acetonitrile–acetic acid (34.5:65.0:0.5, v/v/v) run at a flow rate of 1 mL/min and maintained at room temperature. The calibration curve was linear from 30 to 70 µg/mL with r > 0.999. Accuracy (mean recovery 100.78%) and precision were found to be satisfactory. Stress conditions including acid and alkali hydrolysis, water stress, oxidation, photolysis and heat were applied. The degradation products did not interfere with the detection of loteprednol etabonate, thus the method can be considered as a stability-indicating method. The proposed method can be used for quality control assay of loteprednol etabonate in bulk drug and in ophthalmic suspensions and for stability studies as a result of the ability of the method to separate loteprednol etabonate from its degradation products and excipients.Fil: Han, Yong Ki. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; ArgentinaFil: Segall, Adriana Ines. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; ArgentinaOxford University Press2014-09info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/30541Han, Yong Ki; Segall, Adriana Ines; A Validated Specific Stability-Indicating RP-HPLC Assay Method for the Determination of Loteprednol Etabonate in Eye Drops; Oxford University Press; Journal Of Chromatographic Science; 53; 5; 9-2014; 761-7660021-96651945-239XCONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.1093/chromsci/bmu121info:eu-repo/semantics/altIdentifier/url/https://academic.oup.com/chromsci/article/53/5/761/314738info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-03T10:07:58Zoai:ri.conicet.gov.ar:11336/30541instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-03 10:07:58.406CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv A Validated Specific Stability-Indicating RP-HPLC Assay Method for the Determination of Loteprednol Etabonate in Eye Drops
title A Validated Specific Stability-Indicating RP-HPLC Assay Method for the Determination of Loteprednol Etabonate in Eye Drops
spellingShingle A Validated Specific Stability-Indicating RP-HPLC Assay Method for the Determination of Loteprednol Etabonate in Eye Drops
Han, Yong Ki
Loteprednol Etabonate
Stability Indicating
Validation
Hplc
title_short A Validated Specific Stability-Indicating RP-HPLC Assay Method for the Determination of Loteprednol Etabonate in Eye Drops
title_full A Validated Specific Stability-Indicating RP-HPLC Assay Method for the Determination of Loteprednol Etabonate in Eye Drops
title_fullStr A Validated Specific Stability-Indicating RP-HPLC Assay Method for the Determination of Loteprednol Etabonate in Eye Drops
title_full_unstemmed A Validated Specific Stability-Indicating RP-HPLC Assay Method for the Determination of Loteprednol Etabonate in Eye Drops
title_sort A Validated Specific Stability-Indicating RP-HPLC Assay Method for the Determination of Loteprednol Etabonate in Eye Drops
dc.creator.none.fl_str_mv Han, Yong Ki
Segall, Adriana Ines
author Han, Yong Ki
author_facet Han, Yong Ki
Segall, Adriana Ines
author_role author
author2 Segall, Adriana Ines
author2_role author
dc.subject.none.fl_str_mv Loteprednol Etabonate
Stability Indicating
Validation
Hplc
topic Loteprednol Etabonate
Stability Indicating
Validation
Hplc
purl_subject.fl_str_mv https://purl.org/becyt/ford/1.4
https://purl.org/becyt/ford/1
dc.description.none.fl_txt_mv A new stability-indicating RP-HPLC assay method was developed and validated for quantitative determination of loteprednol etabonate in bulk drugs and in ophthalmic suspensions in the presence of degradation products generated from forced degradation studies. The system consisted of Agilent Technologies Zorbax Eclipse XDB-Phenyl 5 µm 4.6 × 250 mm, and detection was performed at 244 nm. The mobile phase consisted of water–acetonitrile–acetic acid (34.5:65.0:0.5, v/v/v) run at a flow rate of 1 mL/min and maintained at room temperature. The calibration curve was linear from 30 to 70 µg/mL with r > 0.999. Accuracy (mean recovery 100.78%) and precision were found to be satisfactory. Stress conditions including acid and alkali hydrolysis, water stress, oxidation, photolysis and heat were applied. The degradation products did not interfere with the detection of loteprednol etabonate, thus the method can be considered as a stability-indicating method. The proposed method can be used for quality control assay of loteprednol etabonate in bulk drug and in ophthalmic suspensions and for stability studies as a result of the ability of the method to separate loteprednol etabonate from its degradation products and excipients.
Fil: Han, Yong Ki. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentina
Fil: Segall, Adriana Ines. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentina
description A new stability-indicating RP-HPLC assay method was developed and validated for quantitative determination of loteprednol etabonate in bulk drugs and in ophthalmic suspensions in the presence of degradation products generated from forced degradation studies. The system consisted of Agilent Technologies Zorbax Eclipse XDB-Phenyl 5 µm 4.6 × 250 mm, and detection was performed at 244 nm. The mobile phase consisted of water–acetonitrile–acetic acid (34.5:65.0:0.5, v/v/v) run at a flow rate of 1 mL/min and maintained at room temperature. The calibration curve was linear from 30 to 70 µg/mL with r > 0.999. Accuracy (mean recovery 100.78%) and precision were found to be satisfactory. Stress conditions including acid and alkali hydrolysis, water stress, oxidation, photolysis and heat were applied. The degradation products did not interfere with the detection of loteprednol etabonate, thus the method can be considered as a stability-indicating method. The proposed method can be used for quality control assay of loteprednol etabonate in bulk drug and in ophthalmic suspensions and for stability studies as a result of the ability of the method to separate loteprednol etabonate from its degradation products and excipients.
publishDate 2014
dc.date.none.fl_str_mv 2014-09
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/30541
Han, Yong Ki; Segall, Adriana Ines; A Validated Specific Stability-Indicating RP-HPLC Assay Method for the Determination of Loteprednol Etabonate in Eye Drops; Oxford University Press; Journal Of Chromatographic Science; 53; 5; 9-2014; 761-766
0021-9665
1945-239X
CONICET Digital
CONICET
url http://hdl.handle.net/11336/30541
identifier_str_mv Han, Yong Ki; Segall, Adriana Ines; A Validated Specific Stability-Indicating RP-HPLC Assay Method for the Determination of Loteprednol Etabonate in Eye Drops; Oxford University Press; Journal Of Chromatographic Science; 53; 5; 9-2014; 761-766
0021-9665
1945-239X
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/doi/10.1093/chromsci/bmu121
info:eu-repo/semantics/altIdentifier/url/https://academic.oup.com/chromsci/article/53/5/761/314738
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
application/pdf
application/pdf
dc.publisher.none.fl_str_mv Oxford University Press
publisher.none.fl_str_mv Oxford University Press
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
_version_ 1842270025585524736
score 13.13397

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