Development and validation of a high performance liquid 4 chromatography method for oligodeoxynucleotides determination 5 in a novel coagel-based formulation

Autores
Ullio Gamboa, Gabriela Veronica; Llabot, Juan Manuel; Sánchez Vallecillo, María Fernanda; Maletto, Belkys Angélica; Palma, Santiago Daniel; Allemandi, Daniel Alberto
Año de publicación
2015
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
The therapeutic benefit of phosphorothioate oligodeoxynucleotides (PS-ODN) containing immune stimulatory sequences has been demonstrated in animal models of cancer and infection. Several tools are available for the determination of these oligonucleotides in biological samples and pharmaceutical preparations, including UV spectroscopy, dye binding, isotopic tracing, capillary gel electrophoresis (CGE), hybridization-based enzyme-linked immunosorbent assay (ELISA), and chromatography techniques. However, due to inter-assay variability and accuracy problems associated with the afore mentioned methods, we have developed and validated an isocratic high performance liquid chromatographic (HPLC) for analytical determination of PS-ODN containing unmethylated CpG motifs (CpG-ODN). Validation under Food and Drug Administration (FDA) guidelines of the analytical parameters include: linearity (r2 0.9996), LOD (0.86 lg/ml) and LOQ (6.25 lg/ml), intra (0.19?3.37%) and inter-day precision (0.63?3.75%) expressed as relative standard deviation (RSD), and robustness parameters (less than 2.80%). Using this method, recoveries ranging from 89.9% to 99.9% were obtained. Thus, this method provides a simple, sensitive, precise and reproducible examination which can be readily adapted for the assessment of CpG-ODN in different pharmaceutical preparations.
Fil: Ullio Gamboa, Gabriela Veronica. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; Argentina
Fil: Llabot, Juan Manuel. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; Argentina
Fil: Sánchez Vallecillo, María Fernanda. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Córdoba. Centro de Investigaciones en Bioquímica Clínica e Inmunología; Argentina
Fil: Maletto, Belkys Angélica. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Córdoba. Centro de Investigaciones en Bioquímica Clínica e Inmunología; Argentina
Fil: Palma, Santiago Daniel. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; Argentina
Fil: Allemandi, Daniel Alberto. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; Argentina
Materia
ASCORBYL PALMITATE LIQUID CRYSTALS
LIQUID CHROMATOGRAPHY
NUCLEASE STABILITY
OLIGONUCLEOTIDES
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:11336/46049
Acceder
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repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Development and validation of a high performance liquid 4 chromatography method for oligodeoxynucleotides determination 5 in a novel coagel-based formulationUllio Gamboa, Gabriela VeronicaLlabot, Juan ManuelSánchez Vallecillo, María FernandaMaletto, Belkys AngélicaPalma, Santiago DanielAllemandi, Daniel AlbertoASCORBYL PALMITATE LIQUID CRYSTALSLIQUID CHROMATOGRAPHYNUCLEASE STABILITYOLIGONUCLEOTIDEShttps://purl.org/becyt/ford/1.4https://purl.org/becyt/ford/1The therapeutic benefit of phosphorothioate oligodeoxynucleotides (PS-ODN) containing immune stimulatory sequences has been demonstrated in animal models of cancer and infection. Several tools are available for the determination of these oligonucleotides in biological samples and pharmaceutical preparations, including UV spectroscopy, dye binding, isotopic tracing, capillary gel electrophoresis (CGE), hybridization-based enzyme-linked immunosorbent assay (ELISA), and chromatography techniques. However, due to inter-assay variability and accuracy problems associated with the afore mentioned methods, we have developed and validated an isocratic high performance liquid chromatographic (HPLC) for analytical determination of PS-ODN containing unmethylated CpG motifs (CpG-ODN). Validation under Food and Drug Administration (FDA) guidelines of the analytical parameters include: linearity (r2 0.9996), LOD (0.86 lg/ml) and LOQ (6.25 lg/ml), intra (0.19?3.37%) and inter-day precision (0.63?3.75%) expressed as relative standard deviation (RSD), and robustness parameters (less than 2.80%). Using this method, recoveries ranging from 89.9% to 99.9% were obtained. Thus, this method provides a simple, sensitive, precise and reproducible examination which can be readily adapted for the assessment of CpG-ODN in different pharmaceutical preparations.Fil: Ullio Gamboa, Gabriela Veronica. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; ArgentinaFil: Llabot, Juan Manuel. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; ArgentinaFil: Sánchez Vallecillo, María Fernanda. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Córdoba. Centro de Investigaciones en Bioquímica Clínica e Inmunología; ArgentinaFil: Maletto, Belkys Angélica. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Córdoba. Centro de Investigaciones en Bioquímica Clínica e Inmunología; ArgentinaFil: Palma, Santiago Daniel. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; ArgentinaFil: Allemandi, Daniel Alberto. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; ArgentinaElsevier2015-03info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfapplication/pdfapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/46049Ullio Gamboa, Gabriela Veronica; Llabot, Juan Manuel; Sánchez Vallecillo, María Fernanda; Maletto, Belkys Angélica; Palma, Santiago Daniel; et al.; Development and validation of a high performance liquid 4 chromatography method for oligodeoxynucleotides determination 5 in a novel coagel-based formulation; Elsevier; Analytical Chemical Research; 4; 3-2015; 20-242214-1812CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.1016/j.ancr.2015.03.003info:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/pii/S2214181215000075info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-10T12:59:43Zoai:ri.conicet.gov.ar:11336/46049instacron: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:34982025-09-10 12:59:43.775CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Development and validation of a high performance liquid 4 chromatography method for oligodeoxynucleotides determination 5 in a novel coagel-based formulation
title Development and validation of a high performance liquid 4 chromatography method for oligodeoxynucleotides determination 5 in a novel coagel-based formulation
spellingShingle Development and validation of a high performance liquid 4 chromatography method for oligodeoxynucleotides determination 5 in a novel coagel-based formulation
Ullio Gamboa, Gabriela Veronica
ASCORBYL PALMITATE LIQUID CRYSTALS
LIQUID CHROMATOGRAPHY
NUCLEASE STABILITY
OLIGONUCLEOTIDES
title_short Development and validation of a high performance liquid 4 chromatography method for oligodeoxynucleotides determination 5 in a novel coagel-based formulation
title_full Development and validation of a high performance liquid 4 chromatography method for oligodeoxynucleotides determination 5 in a novel coagel-based formulation
title_fullStr Development and validation of a high performance liquid 4 chromatography method for oligodeoxynucleotides determination 5 in a novel coagel-based formulation
title_full_unstemmed Development and validation of a high performance liquid 4 chromatography method for oligodeoxynucleotides determination 5 in a novel coagel-based formulation
title_sort Development and validation of a high performance liquid 4 chromatography method for oligodeoxynucleotides determination 5 in a novel coagel-based formulation
dc.creator.none.fl_str_mv Ullio Gamboa, Gabriela Veronica
Llabot, Juan Manuel
Sánchez Vallecillo, María Fernanda
Maletto, Belkys Angélica
Palma, Santiago Daniel
Allemandi, Daniel Alberto
author Ullio Gamboa, Gabriela Veronica
author_facet Ullio Gamboa, Gabriela Veronica
Llabot, Juan Manuel
Sánchez Vallecillo, María Fernanda
Maletto, Belkys Angélica
Palma, Santiago Daniel
Allemandi, Daniel Alberto
author_role author
author2 Llabot, Juan Manuel
Sánchez Vallecillo, María Fernanda
Maletto, Belkys Angélica
Palma, Santiago Daniel
Allemandi, Daniel Alberto
author2_role author
author
author
author
author
dc.subject.none.fl_str_mv ASCORBYL PALMITATE LIQUID CRYSTALS
LIQUID CHROMATOGRAPHY
NUCLEASE STABILITY
OLIGONUCLEOTIDES
topic ASCORBYL PALMITATE LIQUID CRYSTALS
LIQUID CHROMATOGRAPHY
NUCLEASE STABILITY
OLIGONUCLEOTIDES
purl_subject.fl_str_mv https://purl.org/becyt/ford/1.4
https://purl.org/becyt/ford/1
dc.description.none.fl_txt_mv The therapeutic benefit of phosphorothioate oligodeoxynucleotides (PS-ODN) containing immune stimulatory sequences has been demonstrated in animal models of cancer and infection. Several tools are available for the determination of these oligonucleotides in biological samples and pharmaceutical preparations, including UV spectroscopy, dye binding, isotopic tracing, capillary gel electrophoresis (CGE), hybridization-based enzyme-linked immunosorbent assay (ELISA), and chromatography techniques. However, due to inter-assay variability and accuracy problems associated with the afore mentioned methods, we have developed and validated an isocratic high performance liquid chromatographic (HPLC) for analytical determination of PS-ODN containing unmethylated CpG motifs (CpG-ODN). Validation under Food and Drug Administration (FDA) guidelines of the analytical parameters include: linearity (r2 0.9996), LOD (0.86 lg/ml) and LOQ (6.25 lg/ml), intra (0.19?3.37%) and inter-day precision (0.63?3.75%) expressed as relative standard deviation (RSD), and robustness parameters (less than 2.80%). Using this method, recoveries ranging from 89.9% to 99.9% were obtained. Thus, this method provides a simple, sensitive, precise and reproducible examination which can be readily adapted for the assessment of CpG-ODN in different pharmaceutical preparations.
Fil: Ullio Gamboa, Gabriela Veronica. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; Argentina
Fil: Llabot, Juan Manuel. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; Argentina
Fil: Sánchez Vallecillo, María Fernanda. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Córdoba. Centro de Investigaciones en Bioquímica Clínica e Inmunología; Argentina
Fil: Maletto, Belkys Angélica. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Córdoba. Centro de Investigaciones en Bioquímica Clínica e Inmunología; Argentina
Fil: Palma, Santiago Daniel. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; Argentina
Fil: Allemandi, Daniel Alberto. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; Argentina
description The therapeutic benefit of phosphorothioate oligodeoxynucleotides (PS-ODN) containing immune stimulatory sequences has been demonstrated in animal models of cancer and infection. Several tools are available for the determination of these oligonucleotides in biological samples and pharmaceutical preparations, including UV spectroscopy, dye binding, isotopic tracing, capillary gel electrophoresis (CGE), hybridization-based enzyme-linked immunosorbent assay (ELISA), and chromatography techniques. However, due to inter-assay variability and accuracy problems associated with the afore mentioned methods, we have developed and validated an isocratic high performance liquid chromatographic (HPLC) for analytical determination of PS-ODN containing unmethylated CpG motifs (CpG-ODN). Validation under Food and Drug Administration (FDA) guidelines of the analytical parameters include: linearity (r2 0.9996), LOD (0.86 lg/ml) and LOQ (6.25 lg/ml), intra (0.19?3.37%) and inter-day precision (0.63?3.75%) expressed as relative standard deviation (RSD), and robustness parameters (less than 2.80%). Using this method, recoveries ranging from 89.9% to 99.9% were obtained. Thus, this method provides a simple, sensitive, precise and reproducible examination which can be readily adapted for the assessment of CpG-ODN in different pharmaceutical preparations.
publishDate 2015
dc.date.none.fl_str_mv 2015-03
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/11336/46049
Ullio Gamboa, Gabriela Veronica; Llabot, Juan Manuel; Sánchez Vallecillo, María Fernanda; Maletto, Belkys Angélica; Palma, Santiago Daniel; et al.; Development and validation of a high performance liquid 4 chromatography method for oligodeoxynucleotides determination 5 in a novel coagel-based formulation; Elsevier; Analytical Chemical Research; 4; 3-2015; 20-24
2214-1812
CONICET Digital
CONICET
url http://hdl.handle.net/11336/46049
identifier_str_mv Ullio Gamboa, Gabriela Veronica; Llabot, Juan Manuel; Sánchez Vallecillo, María Fernanda; Maletto, Belkys Angélica; Palma, Santiago Daniel; et al.; Development and validation of a high performance liquid 4 chromatography method for oligodeoxynucleotides determination 5 in a novel coagel-based formulation; Elsevier; Analytical Chemical Research; 4; 3-2015; 20-24
2214-1812
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/doi/10.1016/j.ancr.2015.03.003
info:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/pii/S2214181215000075
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
application/pdf
application/pdf
application/pdf
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
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
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score 12.993085

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