Development and validation of an HPLC-DAD analytical method for quantitative and simultaneous determination of cefoperazone and prednisolone in intramammary ointment

Cefoperazone (CPZ) is a third-generation cephalosporin used to treat bovine mastitis. The association with steroidal anti-inflammatory drugs, such as prednisolone (PRED), provides an improvement in the animal's clinical response, which justifies its use. An analytical method capable of simultan...

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Main Authors: Patrícia Espinosa dos Santos, Jefferson Annunciatto, Teófilo Fernando Mazon Cardoso, Marcos Serrou do Amaral, Nájla Mohamad Kassab
Format: Article
Language:English
Published: Universidade Federal do Rio Grande do Sul 2025-07-01
Series:Drug Analytical Research
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Online Access:https://seer.ufrgs.br/index.php/dar/article/view/146375/96052
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author Patrícia Espinosa dos Santos
Jefferson Annunciatto
Teófilo Fernando Mazon Cardoso
Marcos Serrou do Amaral
Nájla Mohamad Kassab
author_facet Patrícia Espinosa dos Santos
Jefferson Annunciatto
Teófilo Fernando Mazon Cardoso
Marcos Serrou do Amaral
Nájla Mohamad Kassab
author_sort Patrícia Espinosa dos Santos
collection DOAJ
description Cefoperazone (CPZ) is a third-generation cephalosporin used to treat bovine mastitis. The association with steroidal anti-inflammatory drugs, such as prednisolone (PRED), provides an improvement in the animal's clinical response, which justifies its use. An analytical method capable of simultaneously determining the association between CPZ and PRED by High Performance Liquid Chromatography coupled with a Diode Array Detector (HPLC-DAD) was developed. The method was applied in intramammary ointments, showing linearity, for CPZ, from 0.25 to 25 μg mL-1 (r=0.9999); and, for PRED, from 0.75 to 30 μg mL-1 (r=0.9997), with low limits of detection and quantification, precision with coefficients of variation less than 2%, in accuracy, presented recovery close to 100% for both drugs, in addition to demonstrating their robustness by the Youden test, which evaluated the effects and concluded that the altered parameters in the test were not sufficient to change the values obtained in the determinations. The test was also applied to the commercial sample for quality control purposes, with extraction efficiency being 69.66% for CPZ and 72.36% for PRED. Thus, the developed and validated method can be safely applied in the analysis of the studied drugs.
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spelling doaj-art-2d5349121ae0477781f35d6d6b9be3422025-08-20T02:50:32ZengUniversidade Federal do Rio Grande do SulDrug Analytical Research2527-26162025-07-01910312https://doi.org/10.22456/2527-2616.146375Development and validation of an HPLC-DAD analytical method for quantitative and simultaneous determination of cefoperazone and prednisolone in intramammary ointmentPatrícia Espinosa dos Santos0https://orcid.org/0000-0001-7142-0297Jefferson Annunciatto1https://orcid.org/0009-0007-8295-6311Teófilo Fernando Mazon Cardoso2https://orcid.org/0000-0001-7392-7366Marcos Serrou do Amaral3https://orcid.org/0000-0001-8101-6933Nájla Mohamad Kassab4https://orcid.org/0000-0002-9324-4252Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Food, and Nutrition, Federal University of Mato Grosso do Sul, Campo Grande, MS, BrazilPrograma de Pós-Graduação em Ciências Farmacêuticas; Universidade Federal de Mato Grosso do Sul (UFMS), Campo Grande (MS), BrasilFaculdade de Ciências Farmacêuticas, Alimentos e Nutrição, Universidade Federal de Mato Grosso do Sul (UFMS)Instituto de Física, Universidade Federal de Mato Grosso do Sul (UFMS), Campo Grande (MS), BrasilFaculdade de Ciências Farmacêuticas, Alimentos e Nutrição, Universidade Federal de Mato Grosso do Sul (UFMS)Cefoperazone (CPZ) is a third-generation cephalosporin used to treat bovine mastitis. The association with steroidal anti-inflammatory drugs, such as prednisolone (PRED), provides an improvement in the animal's clinical response, which justifies its use. An analytical method capable of simultaneously determining the association between CPZ and PRED by High Performance Liquid Chromatography coupled with a Diode Array Detector (HPLC-DAD) was developed. The method was applied in intramammary ointments, showing linearity, for CPZ, from 0.25 to 25 μg mL-1 (r=0.9999); and, for PRED, from 0.75 to 30 μg mL-1 (r=0.9997), with low limits of detection and quantification, precision with coefficients of variation less than 2%, in accuracy, presented recovery close to 100% for both drugs, in addition to demonstrating their robustness by the Youden test, which evaluated the effects and concluded that the altered parameters in the test were not sufficient to change the values obtained in the determinations. The test was also applied to the commercial sample for quality control purposes, with extraction efficiency being 69.66% for CPZ and 72.36% for PRED. Thus, the developed and validated method can be safely applied in the analysis of the studied drugs.https://seer.ufrgs.br/index.php/dar/article/view/146375/96052cefoperazoneprednisolonevalidationhplcquality control
spellingShingle Patrícia Espinosa dos Santos
Jefferson Annunciatto
Teófilo Fernando Mazon Cardoso
Marcos Serrou do Amaral
Nájla Mohamad Kassab
Development and validation of an HPLC-DAD analytical method for quantitative and simultaneous determination of cefoperazone and prednisolone in intramammary ointment
Drug Analytical Research
cefoperazone
prednisolone
validation
hplc
quality control
title Development and validation of an HPLC-DAD analytical method for quantitative and simultaneous determination of cefoperazone and prednisolone in intramammary ointment
title_full Development and validation of an HPLC-DAD analytical method for quantitative and simultaneous determination of cefoperazone and prednisolone in intramammary ointment
title_fullStr Development and validation of an HPLC-DAD analytical method for quantitative and simultaneous determination of cefoperazone and prednisolone in intramammary ointment
title_full_unstemmed Development and validation of an HPLC-DAD analytical method for quantitative and simultaneous determination of cefoperazone and prednisolone in intramammary ointment
title_short Development and validation of an HPLC-DAD analytical method for quantitative and simultaneous determination of cefoperazone and prednisolone in intramammary ointment
title_sort development and validation of an hplc dad analytical method for quantitative and simultaneous determination of cefoperazone and prednisolone in intramammary ointment
topic cefoperazone
prednisolone
validation
hplc
quality control
url https://seer.ufrgs.br/index.php/dar/article/view/146375/96052
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