Validation of an innovative analytical method for simultaneous quantification of alpha-cyano-4-hydroxycinnamic acid and the monoclonal antibody cetuximab using HPLC from PLGA-based nanoparticles
Autor(a) principal: | |
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Data de Publicação: | 2020 |
Outros Autores: | , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UNESP |
Texto Completo: | http://dx.doi.org/10.1016/j.jpba.2020.113540 http://hdl.handle.net/11449/199278 |
Resumo: | Accumulating evidence has been suggesting that combining two or more anticancer drugs can provide additive or synergistic effects, improving therapeutic efficacy and delaying resistance. Nowadays, advances in nanotechnology-based delivery systems have enabled the association of different drugs into a single carrier and provided therapeutic gains to the proposed regimen. However, a new strategy also requires innovative analytical approaches that assess loading capacity, biological performance, and also comprehend the mechanisms of action. Alpha-cyano-4-hydroxycinnamic acid (CHC) and the monoclonal antibody (mAb) cetuximab (CTX) are explored worldwide for their therapeutic benefits against multiple cancer cells. The present work aims to develop and validate a new method for simultaneous quantification of CHC and CTX in nanoparticulate systems by using reverse phase high-performance liquid chromatography (RP-HPLC) with ultraviolet (UV) detection for CHC, and fluorescence detection for CTX. This method was designed following the guidelines of the International Conference on Harmonization ICH Q2 (R1) and the Food and Drug Administration (FDA) - Guidance for Bioanalytical Method Validation. Chromatographic separation was performed on a C18 column with the mobile phase composed by water, 0.1 % (v/v) trifluoroacetic acid (TFA) and acetonitrile (ACN)-0.1 % TFA on gradient mode at a flow rate of 0.6 mL/min. The performance of the present method was evaluated by system suitability; therefore, linearity, accuracy, precision, detection, limit of detection / limit of quantification, and robustness were also highlighted. Specificity was demonstrated by the chromatographic analyses of CHC and CTX, subjected to several informative stress conditions. The developed method was also successfully used for the first time to quantify the CHC and CTX content in poly(lactic-co-glycolic acid)-based nanoparticles. In conclusion, this new and rapid method presented acceptable analytical performance and can be helpful to simultaneously quantify CHC and CTX in future studies applied to anticancer therapy. |
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Validation of an innovative analytical method for simultaneous quantification of alpha-cyano-4-hydroxycinnamic acid and the monoclonal antibody cetuximab using HPLC from PLGA-based nanoparticlesAlpha-cyano-4-hydroxycinnamic acidCetuximabExperimental anticancer drugMethod validationPoly(lactic-co-glycolic acid)-based nanoparticlesReversed phase HPLCAccumulating evidence has been suggesting that combining two or more anticancer drugs can provide additive or synergistic effects, improving therapeutic efficacy and delaying resistance. Nowadays, advances in nanotechnology-based delivery systems have enabled the association of different drugs into a single carrier and provided therapeutic gains to the proposed regimen. However, a new strategy also requires innovative analytical approaches that assess loading capacity, biological performance, and also comprehend the mechanisms of action. Alpha-cyano-4-hydroxycinnamic acid (CHC) and the monoclonal antibody (mAb) cetuximab (CTX) are explored worldwide for their therapeutic benefits against multiple cancer cells. The present work aims to develop and validate a new method for simultaneous quantification of CHC and CTX in nanoparticulate systems by using reverse phase high-performance liquid chromatography (RP-HPLC) with ultraviolet (UV) detection for CHC, and fluorescence detection for CTX. This method was designed following the guidelines of the International Conference on Harmonization ICH Q2 (R1) and the Food and Drug Administration (FDA) - Guidance for Bioanalytical Method Validation. Chromatographic separation was performed on a C18 column with the mobile phase composed by water, 0.1 % (v/v) trifluoroacetic acid (TFA) and acetonitrile (ACN)-0.1 % TFA on gradient mode at a flow rate of 0.6 mL/min. The performance of the present method was evaluated by system suitability; therefore, linearity, accuracy, precision, detection, limit of detection / limit of quantification, and robustness were also highlighted. Specificity was demonstrated by the chromatographic analyses of CHC and CTX, subjected to several informative stress conditions. The developed method was also successfully used for the first time to quantify the CHC and CTX content in poly(lactic-co-glycolic acid)-based nanoparticles. In conclusion, this new and rapid method presented acceptable analytical performance and can be helpful to simultaneously quantify CHC and CTX in future studies applied to anticancer therapy.Fundação para a Ciência e a TecnologiaEuropean Regional Development FundSchool of Pharmaceutical Sciences São Paulo State University UNESP, Rodovia Araraquara-Jaú km 01, AraraquaraLife and Health Sciences Research Institute (ICVS) School of Medicine University of MinhoICVS/3B's-PT Government Associate LaboratorySchool of Pharmaceutical Sciences São Paulo State University UNESP, Rodovia Araraquara-Jaú km 01, AraraquaraUniversidade Estadual Paulista (Unesp)University of MinhoICVS/3B's-PT Government Associate LaboratoryFerreira, Natália N. [UNESP]Boni, Fernanda I. [UNESP]Baltazar, FátimaGremião, Maria P.D. [UNESP]2020-12-12T01:35:27Z2020-12-12T01:35:27Z2020-10-25info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlehttp://dx.doi.org/10.1016/j.jpba.2020.113540Journal of Pharmaceutical and Biomedical Analysis, v. 190.1873-264X0731-7085http://hdl.handle.net/11449/19927810.1016/j.jpba.2020.1135402-s2.0-85089662807Scopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengJournal of Pharmaceutical and Biomedical Analysisinfo:eu-repo/semantics/openAccess2021-10-23T06:44:41Zoai:repositorio.unesp.br:11449/199278Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462021-10-23T06:44:41Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false |
dc.title.none.fl_str_mv |
Validation of an innovative analytical method for simultaneous quantification of alpha-cyano-4-hydroxycinnamic acid and the monoclonal antibody cetuximab using HPLC from PLGA-based nanoparticles |
title |
Validation of an innovative analytical method for simultaneous quantification of alpha-cyano-4-hydroxycinnamic acid and the monoclonal antibody cetuximab using HPLC from PLGA-based nanoparticles |
spellingShingle |
Validation of an innovative analytical method for simultaneous quantification of alpha-cyano-4-hydroxycinnamic acid and the monoclonal antibody cetuximab using HPLC from PLGA-based nanoparticles Ferreira, Natália N. [UNESP] Alpha-cyano-4-hydroxycinnamic acid Cetuximab Experimental anticancer drug Method validation Poly(lactic-co-glycolic acid)-based nanoparticles Reversed phase HPLC |
title_short |
Validation of an innovative analytical method for simultaneous quantification of alpha-cyano-4-hydroxycinnamic acid and the monoclonal antibody cetuximab using HPLC from PLGA-based nanoparticles |
title_full |
Validation of an innovative analytical method for simultaneous quantification of alpha-cyano-4-hydroxycinnamic acid and the monoclonal antibody cetuximab using HPLC from PLGA-based nanoparticles |
title_fullStr |
Validation of an innovative analytical method for simultaneous quantification of alpha-cyano-4-hydroxycinnamic acid and the monoclonal antibody cetuximab using HPLC from PLGA-based nanoparticles |
title_full_unstemmed |
Validation of an innovative analytical method for simultaneous quantification of alpha-cyano-4-hydroxycinnamic acid and the monoclonal antibody cetuximab using HPLC from PLGA-based nanoparticles |
title_sort |
Validation of an innovative analytical method for simultaneous quantification of alpha-cyano-4-hydroxycinnamic acid and the monoclonal antibody cetuximab using HPLC from PLGA-based nanoparticles |
author |
Ferreira, Natália N. [UNESP] |
author_facet |
Ferreira, Natália N. [UNESP] Boni, Fernanda I. [UNESP] Baltazar, Fátima Gremião, Maria P.D. [UNESP] |
author_role |
author |
author2 |
Boni, Fernanda I. [UNESP] Baltazar, Fátima Gremião, Maria P.D. [UNESP] |
author2_role |
author author author |
dc.contributor.none.fl_str_mv |
Universidade Estadual Paulista (Unesp) University of Minho ICVS/3B's-PT Government Associate Laboratory |
dc.contributor.author.fl_str_mv |
Ferreira, Natália N. [UNESP] Boni, Fernanda I. [UNESP] Baltazar, Fátima Gremião, Maria P.D. [UNESP] |
dc.subject.por.fl_str_mv |
Alpha-cyano-4-hydroxycinnamic acid Cetuximab Experimental anticancer drug Method validation Poly(lactic-co-glycolic acid)-based nanoparticles Reversed phase HPLC |
topic |
Alpha-cyano-4-hydroxycinnamic acid Cetuximab Experimental anticancer drug Method validation Poly(lactic-co-glycolic acid)-based nanoparticles Reversed phase HPLC |
description |
Accumulating evidence has been suggesting that combining two or more anticancer drugs can provide additive or synergistic effects, improving therapeutic efficacy and delaying resistance. Nowadays, advances in nanotechnology-based delivery systems have enabled the association of different drugs into a single carrier and provided therapeutic gains to the proposed regimen. However, a new strategy also requires innovative analytical approaches that assess loading capacity, biological performance, and also comprehend the mechanisms of action. Alpha-cyano-4-hydroxycinnamic acid (CHC) and the monoclonal antibody (mAb) cetuximab (CTX) are explored worldwide for their therapeutic benefits against multiple cancer cells. The present work aims to develop and validate a new method for simultaneous quantification of CHC and CTX in nanoparticulate systems by using reverse phase high-performance liquid chromatography (RP-HPLC) with ultraviolet (UV) detection for CHC, and fluorescence detection for CTX. This method was designed following the guidelines of the International Conference on Harmonization ICH Q2 (R1) and the Food and Drug Administration (FDA) - Guidance for Bioanalytical Method Validation. Chromatographic separation was performed on a C18 column with the mobile phase composed by water, 0.1 % (v/v) trifluoroacetic acid (TFA) and acetonitrile (ACN)-0.1 % TFA on gradient mode at a flow rate of 0.6 mL/min. The performance of the present method was evaluated by system suitability; therefore, linearity, accuracy, precision, detection, limit of detection / limit of quantification, and robustness were also highlighted. Specificity was demonstrated by the chromatographic analyses of CHC and CTX, subjected to several informative stress conditions. The developed method was also successfully used for the first time to quantify the CHC and CTX content in poly(lactic-co-glycolic acid)-based nanoparticles. In conclusion, this new and rapid method presented acceptable analytical performance and can be helpful to simultaneously quantify CHC and CTX in future studies applied to anticancer therapy. |
publishDate |
2020 |
dc.date.none.fl_str_mv |
2020-12-12T01:35:27Z 2020-12-12T01:35:27Z 2020-10-25 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://dx.doi.org/10.1016/j.jpba.2020.113540 Journal of Pharmaceutical and Biomedical Analysis, v. 190. 1873-264X 0731-7085 http://hdl.handle.net/11449/199278 10.1016/j.jpba.2020.113540 2-s2.0-85089662807 |
url |
http://dx.doi.org/10.1016/j.jpba.2020.113540 http://hdl.handle.net/11449/199278 |
identifier_str_mv |
Journal of Pharmaceutical and Biomedical Analysis, v. 190. 1873-264X 0731-7085 10.1016/j.jpba.2020.113540 2-s2.0-85089662807 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
Journal of Pharmaceutical and Biomedical Analysis |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.source.none.fl_str_mv |
Scopus reponame:Repositório Institucional da UNESP instname:Universidade Estadual Paulista (UNESP) instacron:UNESP |
instname_str |
Universidade Estadual Paulista (UNESP) |
instacron_str |
UNESP |
institution |
UNESP |
reponame_str |
Repositório Institucional da UNESP |
collection |
Repositório Institucional da UNESP |
repository.name.fl_str_mv |
Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP) |
repository.mail.fl_str_mv |
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