Development and Validation of an Leo-Friendly and Low-Cost Method for the Quantification of Cefepime Hydrochloride in Powder for Injectable Solution Using Infrared (IR) Spectroscopy
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/10.2124/1573411014666180704122816 http://hdl.handle.net/11449/195423 |
Resumo: | Background: A simple, eco-friendly and low-cost Infrared (IR) method was developed and validated for the analysis of Cefepime. Hydrochloride (CEF) in injectable formulation. Different from some other methods, which employ organic solvents in the analyses, this technique does not use these types of solvents, removing large impacts on the environment and risks to operators. Objective: This study aimed at developing and validating a green analytical method using IR spectroscopy for the determination of CEF in pharmaceutical preparations. Methods: The method was validated according to guidelines and the quantification of CEF was performed in the spectral region absorbed at 1815-1745 cm(-1) (stretching of the carbonyl group of beta-lactam ring). Results: The validated method showed to be linear (r = 0.9999) in the range of 0.2 to 0.6 mg/pellet of potassium bromide, as well as for the parameters of selectivity, precision, accuracy, robustness and Limits of Detection (LOD) and Quantification (LOQ), being able to quantify the CEF in pharmaceutical preparations. The CEF content obtained by the IR method was 103.86%. Conclusion: Thus, the method developed may be an alternative in the quality control of CEF sample in lyophilized powder for injectable solution, as it presented important characteristics in the determination of the pharmaceutical products, with low analysis time and a decrease in the generation of toxic wastes to the environment. |
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Development and Validation of an Leo-Friendly and Low-Cost Method for the Quantification of Cefepime Hydrochloride in Powder for Injectable Solution Using Infrared (IR) SpectroscopyCefepime hydrochloridegreen chemistrypharmaceutical analysisquality controlspectroscopyvalidationBackground: A simple, eco-friendly and low-cost Infrared (IR) method was developed and validated for the analysis of Cefepime. Hydrochloride (CEF) in injectable formulation. Different from some other methods, which employ organic solvents in the analyses, this technique does not use these types of solvents, removing large impacts on the environment and risks to operators. Objective: This study aimed at developing and validating a green analytical method using IR spectroscopy for the determination of CEF in pharmaceutical preparations. Methods: The method was validated according to guidelines and the quantification of CEF was performed in the spectral region absorbed at 1815-1745 cm(-1) (stretching of the carbonyl group of beta-lactam ring). Results: The validated method showed to be linear (r = 0.9999) in the range of 0.2 to 0.6 mg/pellet of potassium bromide, as well as for the parameters of selectivity, precision, accuracy, robustness and Limits of Detection (LOD) and Quantification (LOQ), being able to quantify the CEF in pharmaceutical preparations. The CEF content obtained by the IR method was 103.86%. Conclusion: Thus, the method developed may be an alternative in the quality control of CEF sample in lyophilized powder for injectable solution, as it presented important characteristics in the determination of the pharmaceutical products, with low analysis time and a decrease in the generation of toxic wastes to the environment.Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)Univ Estadual Paulista, UNESP, Sch Pharmaceut Sci, Dept Pharmaceut, POB, BR-14801902 Araraquara, SP, BrazilUniv Estadual Paulista, UNESP, Sch Pharmaceut Sci, Dept Pharmaceut, POB, BR-14801902 Araraquara, SP, BrazilFAPESP: 2013/20017-5FAPESP: 2015/01551-6Bentham Science Publ LtdUniversidade Estadual Paulista (Unesp)Rodrigues, Danilo F. [UNESP]Salgado, Herida R. N. [UNESP]2020-12-10T17:34:13Z2020-12-10T17:34:13Z2020-01-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article456-464http://dx.doi.org/10.2124/1573411014666180704122816Current Analytical Chemistry. Sharjah: Bentham Science Publ Ltd, v. 16, n. 4, p. 456-464, 2020.1573-4110http://hdl.handle.net/11449/19542310.2124/1573411014666180704122816WOS:000538151800011Web of Sciencereponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengCurrent Analytical Chemistryinfo:eu-repo/semantics/openAccess2021-10-23T07:53:02Zoai:repositorio.unesp.br:11449/195423Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-08-05T14:59:55.039269Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false |
dc.title.none.fl_str_mv |
Development and Validation of an Leo-Friendly and Low-Cost Method for the Quantification of Cefepime Hydrochloride in Powder for Injectable Solution Using Infrared (IR) Spectroscopy |
title |
Development and Validation of an Leo-Friendly and Low-Cost Method for the Quantification of Cefepime Hydrochloride in Powder for Injectable Solution Using Infrared (IR) Spectroscopy |
spellingShingle |
Development and Validation of an Leo-Friendly and Low-Cost Method for the Quantification of Cefepime Hydrochloride in Powder for Injectable Solution Using Infrared (IR) Spectroscopy Rodrigues, Danilo F. [UNESP] Cefepime hydrochloride green chemistry pharmaceutical analysis quality control spectroscopy validation |
title_short |
Development and Validation of an Leo-Friendly and Low-Cost Method for the Quantification of Cefepime Hydrochloride in Powder for Injectable Solution Using Infrared (IR) Spectroscopy |
title_full |
Development and Validation of an Leo-Friendly and Low-Cost Method for the Quantification of Cefepime Hydrochloride in Powder for Injectable Solution Using Infrared (IR) Spectroscopy |
title_fullStr |
Development and Validation of an Leo-Friendly and Low-Cost Method for the Quantification of Cefepime Hydrochloride in Powder for Injectable Solution Using Infrared (IR) Spectroscopy |
title_full_unstemmed |
Development and Validation of an Leo-Friendly and Low-Cost Method for the Quantification of Cefepime Hydrochloride in Powder for Injectable Solution Using Infrared (IR) Spectroscopy |
title_sort |
Development and Validation of an Leo-Friendly and Low-Cost Method for the Quantification of Cefepime Hydrochloride in Powder for Injectable Solution Using Infrared (IR) Spectroscopy |
author |
Rodrigues, Danilo F. [UNESP] |
author_facet |
Rodrigues, Danilo F. [UNESP] Salgado, Herida R. N. [UNESP] |
author_role |
author |
author2 |
Salgado, Herida R. N. [UNESP] |
author2_role |
author |
dc.contributor.none.fl_str_mv |
Universidade Estadual Paulista (Unesp) |
dc.contributor.author.fl_str_mv |
Rodrigues, Danilo F. [UNESP] Salgado, Herida R. N. [UNESP] |
dc.subject.por.fl_str_mv |
Cefepime hydrochloride green chemistry pharmaceutical analysis quality control spectroscopy validation |
topic |
Cefepime hydrochloride green chemistry pharmaceutical analysis quality control spectroscopy validation |
description |
Background: A simple, eco-friendly and low-cost Infrared (IR) method was developed and validated for the analysis of Cefepime. Hydrochloride (CEF) in injectable formulation. Different from some other methods, which employ organic solvents in the analyses, this technique does not use these types of solvents, removing large impacts on the environment and risks to operators. Objective: This study aimed at developing and validating a green analytical method using IR spectroscopy for the determination of CEF in pharmaceutical preparations. Methods: The method was validated according to guidelines and the quantification of CEF was performed in the spectral region absorbed at 1815-1745 cm(-1) (stretching of the carbonyl group of beta-lactam ring). Results: The validated method showed to be linear (r = 0.9999) in the range of 0.2 to 0.6 mg/pellet of potassium bromide, as well as for the parameters of selectivity, precision, accuracy, robustness and Limits of Detection (LOD) and Quantification (LOQ), being able to quantify the CEF in pharmaceutical preparations. The CEF content obtained by the IR method was 103.86%. Conclusion: Thus, the method developed may be an alternative in the quality control of CEF sample in lyophilized powder for injectable solution, as it presented important characteristics in the determination of the pharmaceutical products, with low analysis time and a decrease in the generation of toxic wastes to the environment. |
publishDate |
2020 |
dc.date.none.fl_str_mv |
2020-12-10T17:34:13Z 2020-12-10T17:34:13Z 2020-01-01 |
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/10.2124/1573411014666180704122816 Current Analytical Chemistry. Sharjah: Bentham Science Publ Ltd, v. 16, n. 4, p. 456-464, 2020. 1573-4110 http://hdl.handle.net/11449/195423 10.2124/1573411014666180704122816 WOS:000538151800011 |
url |
http://dx.doi.org/10.2124/1573411014666180704122816 http://hdl.handle.net/11449/195423 |
identifier_str_mv |
Current Analytical Chemistry. Sharjah: Bentham Science Publ Ltd, v. 16, n. 4, p. 456-464, 2020. 1573-4110 10.2124/1573411014666180704122816 WOS:000538151800011 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
Current Analytical Chemistry |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
456-464 |
dc.publisher.none.fl_str_mv |
Bentham Science Publ Ltd |
publisher.none.fl_str_mv |
Bentham Science Publ Ltd |
dc.source.none.fl_str_mv |
Web of Science 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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1808128445420404736 |