Stability indicating RP-HPLC method development and validation of cefepime and amikacin in pure and pharmaceutical dosage forms

Detalhes bibliográficos
Autor(a) principal: Kalyani, Lella
Data de Publicação: 2018
Outros Autores: Rao, Chava Venkata Nageswara
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Brazilian Journal of Pharmaceutical Sciences
Texto Completo: https://www.revistas.usp.br/bjps/article/view/153838
Resumo: A simple, accurate, isocratic stability indicating RP‐HPLC method was developed for the determination of cefepime and amikacin in Pure and its pharmaceutical formulations. The method consists of methanol: acetonitrile:acetate buffer 75:20:05 (v/v) mobile phase at pH 5.1 with C18 column as stationary phase. The flow rate and detection wave length were 1.0 mL/min and 212 nm respectively. The linearity range for the method was found to be 2.5-25 µg/mL for amikacin and 10-100 µg/mL cefepime respectively. The developed method was validated as per ICH guidelines and the results of all the validation parameters were well within their acceptance values. Also the forced degradation studies were conducted with standard drugs. Degradation products formed during the different stress conditions were separated from both drugs. This validated method was applied for the simultaneous estimation of cefepime and amikacin in commercially available formulation sample.
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spelling Stability indicating RP-HPLC method development and validation of cefepime and amikacin in pure and pharmaceutical dosage formsCefepime/method development and validationAmikacin/method development and validationRP-HPLCA simple, accurate, isocratic stability indicating RP‐HPLC method was developed for the determination of cefepime and amikacin in Pure and its pharmaceutical formulations. The method consists of methanol: acetonitrile:acetate buffer 75:20:05 (v/v) mobile phase at pH 5.1 with C18 column as stationary phase. The flow rate and detection wave length were 1.0 mL/min and 212 nm respectively. The linearity range for the method was found to be 2.5-25 µg/mL for amikacin and 10-100 µg/mL cefepime respectively. The developed method was validated as per ICH guidelines and the results of all the validation parameters were well within their acceptance values. Also the forced degradation studies were conducted with standard drugs. Degradation products formed during the different stress conditions were separated from both drugs. This validated method was applied for the simultaneous estimation of cefepime and amikacin in commercially available formulation sample.Universidade de São Paulo. Faculdade de Ciências Farmacêuticas2018-11-29info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://www.revistas.usp.br/bjps/article/view/15383810.1590/s2175-97902018000317258Brazilian Journal of Pharmaceutical Sciences; Vol. 54 Núm. 3 (2018); e17258Brazilian Journal of Pharmaceutical Sciences; v. 54 n. 3 (2018); e17258Brazilian Journal of Pharmaceutical Sciences; Vol. 54 No. 3 (2018); e172582175-97901984-8250reponame:Brazilian Journal of Pharmaceutical Sciencesinstname:Universidade de São Paulo (USP)instacron:USPenghttps://www.revistas.usp.br/bjps/article/view/153838/150203Copyright (c) 2018 Brazilian Journal of Pharmaceutical Sciences (Impresso)info:eu-repo/semantics/openAccessKalyani, LellaRao, Chava Venkata Nageswara2019-03-17T12:49:11Zoai:revistas.usp.br:article/153838Revistahttps://www.revistas.usp.br/bjps/indexPUBhttps://old.scielo.br/oai/scielo-oai.phpbjps@usp.br||elizabeth.igne@gmail.com2175-97901984-8250opendoar:2019-03-17T12:49:11Brazilian Journal of Pharmaceutical Sciences - Universidade de São Paulo (USP)false
dc.title.none.fl_str_mv Stability indicating RP-HPLC method development and validation of cefepime and amikacin in pure and pharmaceutical dosage forms
title Stability indicating RP-HPLC method development and validation of cefepime and amikacin in pure and pharmaceutical dosage forms
spellingShingle Stability indicating RP-HPLC method development and validation of cefepime and amikacin in pure and pharmaceutical dosage forms
Kalyani, Lella
Cefepime/method development and validation
Amikacin/method development and validation
RP-HPLC
title_short Stability indicating RP-HPLC method development and validation of cefepime and amikacin in pure and pharmaceutical dosage forms
title_full Stability indicating RP-HPLC method development and validation of cefepime and amikacin in pure and pharmaceutical dosage forms
title_fullStr Stability indicating RP-HPLC method development and validation of cefepime and amikacin in pure and pharmaceutical dosage forms
title_full_unstemmed Stability indicating RP-HPLC method development and validation of cefepime and amikacin in pure and pharmaceutical dosage forms
title_sort Stability indicating RP-HPLC method development and validation of cefepime and amikacin in pure and pharmaceutical dosage forms
author Kalyani, Lella
author_facet Kalyani, Lella
Rao, Chava Venkata Nageswara
author_role author
author2 Rao, Chava Venkata Nageswara
author2_role author
dc.contributor.author.fl_str_mv Kalyani, Lella
Rao, Chava Venkata Nageswara
dc.subject.por.fl_str_mv Cefepime/method development and validation
Amikacin/method development and validation
RP-HPLC
topic Cefepime/method development and validation
Amikacin/method development and validation
RP-HPLC
description A simple, accurate, isocratic stability indicating RP‐HPLC method was developed for the determination of cefepime and amikacin in Pure and its pharmaceutical formulations. The method consists of methanol: acetonitrile:acetate buffer 75:20:05 (v/v) mobile phase at pH 5.1 with C18 column as stationary phase. The flow rate and detection wave length were 1.0 mL/min and 212 nm respectively. The linearity range for the method was found to be 2.5-25 µg/mL for amikacin and 10-100 µg/mL cefepime respectively. The developed method was validated as per ICH guidelines and the results of all the validation parameters were well within their acceptance values. Also the forced degradation studies were conducted with standard drugs. Degradation products formed during the different stress conditions were separated from both drugs. This validated method was applied for the simultaneous estimation of cefepime and amikacin in commercially available formulation sample.
publishDate 2018
dc.date.none.fl_str_mv 2018-11-29
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://www.revistas.usp.br/bjps/article/view/153838
10.1590/s2175-97902018000317258
url https://www.revistas.usp.br/bjps/article/view/153838
identifier_str_mv 10.1590/s2175-97902018000317258
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv https://www.revistas.usp.br/bjps/article/view/153838/150203
dc.rights.driver.fl_str_mv Copyright (c) 2018 Brazilian Journal of Pharmaceutical Sciences (Impresso)
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Copyright (c) 2018 Brazilian Journal of Pharmaceutical Sciences (Impresso)
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Universidade de São Paulo. Faculdade de Ciências Farmacêuticas
publisher.none.fl_str_mv Universidade de São Paulo. Faculdade de Ciências Farmacêuticas
dc.source.none.fl_str_mv Brazilian Journal of Pharmaceutical Sciences; Vol. 54 Núm. 3 (2018); e17258
Brazilian Journal of Pharmaceutical Sciences; v. 54 n. 3 (2018); e17258
Brazilian Journal of Pharmaceutical Sciences; Vol. 54 No. 3 (2018); e17258
2175-9790
1984-8250
reponame:Brazilian Journal of Pharmaceutical Sciences
instname:Universidade de São Paulo (USP)
instacron:USP
instname_str Universidade de São Paulo (USP)
instacron_str USP
institution USP
reponame_str Brazilian Journal of Pharmaceutical Sciences
collection Brazilian Journal of Pharmaceutical Sciences
repository.name.fl_str_mv Brazilian Journal of Pharmaceutical Sciences - Universidade de São Paulo (USP)
repository.mail.fl_str_mv bjps@usp.br||elizabeth.igne@gmail.com
_version_ 1800222913776844800

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