Development and validation of an HPLC-UV method for accelerated stability study and pharmacokinetic analysis of venlafaxine

Detalhes bibliográficos
Autor(a) principal: Sher, Muhammad
Data de Publicação: 2020
Outros Autores: Ahmad, Maria, Hassan, Faiza, Naeem-ul-Hassan, Muhammad, Hussain, Muhammad Ajaz
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Brazilian Journal of Pharmaceutical Sciences
Texto Completo: https://www.revistas.usp.br/bjps/article/view/181384
Resumo: A reverse phase high performance liquid chromatography method has been developed and validated for accelerated stability study and determination of pharmacokinetic parameters of venlafaxine HCl. The chromatographic separation was carried out using ODS analytical column (250 × 4.6 mm i.d., 5 μm particle size). The mobile phase included acetonitrile, methanol and potassium dihydrogen phosphate buffer (30:30:40; pH 6.1) at a flow rate 1.5 mL min−1. UV-Visible detector was used at wavelength of 227 nm to monitor elutions. Retention time observed was 2.745 min. The method was validated for linearity, accuracy, precision, sensitivity and robustness. Accelerated stability study of venlafaxine HCl capsules was carried out at 40 and 50 °C under 75% RH level. Suggested method was successfully applied for the pharmacokinetic analysis of venlafaxine hydrochloride tablets. Each of ten albino rabbits (≈ 1.2 kg each) was orally administered with 5 mg dose of venlafaxine HCl. The method was proved to be linear (R2 >0.998), accurate (98.25-99.27%), sensitive (LOD: 35ngmL−1; LOQ: 105 ng mL−1) and robust (RSD<1%). The drug showed stability at accelerated conditions of temperature and humidity. The main pharmacokinetic parameters of tested products were as follows: tmax was 2.5h, Cmax was 56.5 μg mL−1, t1/2 was 8.2 h, AUC0-36 was 845.9 μg h mL−1. The developed method is suitable to apply for quality control analysis and pharmacokinetic studies.
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spelling Development and validation of an HPLC-UV method for accelerated stability study and pharmacokinetic analysis of venlafaxineVenlafaxineHPLCStabilityPharmacokineticsChromatographyA reverse phase high performance liquid chromatography method has been developed and validated for accelerated stability study and determination of pharmacokinetic parameters of venlafaxine HCl. The chromatographic separation was carried out using ODS analytical column (250 × 4.6 mm i.d., 5 μm particle size). The mobile phase included acetonitrile, methanol and potassium dihydrogen phosphate buffer (30:30:40; pH 6.1) at a flow rate 1.5 mL min−1. UV-Visible detector was used at wavelength of 227 nm to monitor elutions. Retention time observed was 2.745 min. The method was validated for linearity, accuracy, precision, sensitivity and robustness. Accelerated stability study of venlafaxine HCl capsules was carried out at 40 and 50 °C under 75% RH level. Suggested method was successfully applied for the pharmacokinetic analysis of venlafaxine hydrochloride tablets. Each of ten albino rabbits (≈ 1.2 kg each) was orally administered with 5 mg dose of venlafaxine HCl. The method was proved to be linear (R2 >0.998), accurate (98.25-99.27%), sensitive (LOD: 35ngmL−1; LOQ: 105 ng mL−1) and robust (RSD<1%). The drug showed stability at accelerated conditions of temperature and humidity. The main pharmacokinetic parameters of tested products were as follows: tmax was 2.5h, Cmax was 56.5 μg mL−1, t1/2 was 8.2 h, AUC0-36 was 845.9 μg h mL−1. The developed method is suitable to apply for quality control analysis and pharmacokinetic studies.Universidade de São Paulo. Faculdade de Ciências Farmacêuticas2020-12-09info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://www.revistas.usp.br/bjps/article/view/18138410.1590/s2175-97902019000217728Brazilian Journal of Pharmaceutical Sciences; Vol. 56 (2020); e17728 Brazilian Journal of Pharmaceutical Sciences; v. 56 (2020); e17728 Brazilian Journal of Pharmaceutical Sciences; Vol. 56 (2020); e17728 2175-97901984-8250reponame:Brazilian Journal of Pharmaceutical Sciencesinstname:Universidade de São Paulo (USP)instacron:USPenghttps://www.revistas.usp.br/bjps/article/view/181384/168254Copyright (c) 2020 Brazilian Journal of Pharmaceutical Scienceshttp://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessSher, Muhammad Ahmad, Maria Hassan, Faiza Naeem-ul-Hassan, Muhammad Hussain, Muhammad Ajaz 2021-06-12T19:46:54Zoai:revistas.usp.br:article/181384Revistahttps://www.revistas.usp.br/bjps/indexPUBhttps://old.scielo.br/oai/scielo-oai.phpbjps@usp.br||elizabeth.igne@gmail.com2175-97901984-8250opendoar:2021-06-12T19:46:54Brazilian Journal of Pharmaceutical Sciences - Universidade de São Paulo (USP)false
dc.title.none.fl_str_mv Development and validation of an HPLC-UV method for accelerated stability study and pharmacokinetic analysis of venlafaxine
title Development and validation of an HPLC-UV method for accelerated stability study and pharmacokinetic analysis of venlafaxine
spellingShingle Development and validation of an HPLC-UV method for accelerated stability study and pharmacokinetic analysis of venlafaxine
Sher, Muhammad
Venlafaxine
HPLC
Stability
Pharmacokinetics
Chromatography
title_short Development and validation of an HPLC-UV method for accelerated stability study and pharmacokinetic analysis of venlafaxine
title_full Development and validation of an HPLC-UV method for accelerated stability study and pharmacokinetic analysis of venlafaxine
title_fullStr Development and validation of an HPLC-UV method for accelerated stability study and pharmacokinetic analysis of venlafaxine
title_full_unstemmed Development and validation of an HPLC-UV method for accelerated stability study and pharmacokinetic analysis of venlafaxine
title_sort Development and validation of an HPLC-UV method for accelerated stability study and pharmacokinetic analysis of venlafaxine
author Sher, Muhammad
author_facet Sher, Muhammad
Ahmad, Maria
Hassan, Faiza
Naeem-ul-Hassan, Muhammad
Hussain, Muhammad Ajaz
author_role author
author2 Ahmad, Maria
Hassan, Faiza
Naeem-ul-Hassan, Muhammad
Hussain, Muhammad Ajaz
author2_role author
author
author
author
dc.contributor.author.fl_str_mv Sher, Muhammad
Ahmad, Maria
Hassan, Faiza
Naeem-ul-Hassan, Muhammad
Hussain, Muhammad Ajaz
dc.subject.por.fl_str_mv Venlafaxine
HPLC
Stability
Pharmacokinetics
Chromatography
topic Venlafaxine
HPLC
Stability
Pharmacokinetics
Chromatography
description A reverse phase high performance liquid chromatography method has been developed and validated for accelerated stability study and determination of pharmacokinetic parameters of venlafaxine HCl. The chromatographic separation was carried out using ODS analytical column (250 × 4.6 mm i.d., 5 μm particle size). The mobile phase included acetonitrile, methanol and potassium dihydrogen phosphate buffer (30:30:40; pH 6.1) at a flow rate 1.5 mL min−1. UV-Visible detector was used at wavelength of 227 nm to monitor elutions. Retention time observed was 2.745 min. The method was validated for linearity, accuracy, precision, sensitivity and robustness. Accelerated stability study of venlafaxine HCl capsules was carried out at 40 and 50 °C under 75% RH level. Suggested method was successfully applied for the pharmacokinetic analysis of venlafaxine hydrochloride tablets. Each of ten albino rabbits (≈ 1.2 kg each) was orally administered with 5 mg dose of venlafaxine HCl. The method was proved to be linear (R2 >0.998), accurate (98.25-99.27%), sensitive (LOD: 35ngmL−1; LOQ: 105 ng mL−1) and robust (RSD<1%). The drug showed stability at accelerated conditions of temperature and humidity. The main pharmacokinetic parameters of tested products were as follows: tmax was 2.5h, Cmax was 56.5 μg mL−1, t1/2 was 8.2 h, AUC0-36 was 845.9 μg h mL−1. The developed method is suitable to apply for quality control analysis and pharmacokinetic studies.
publishDate 2020
dc.date.none.fl_str_mv 2020-12-09
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/181384
10.1590/s2175-97902019000217728
url https://www.revistas.usp.br/bjps/article/view/181384
identifier_str_mv 10.1590/s2175-97902019000217728
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv https://www.revistas.usp.br/bjps/article/view/181384/168254
dc.rights.driver.fl_str_mv Copyright (c) 2020 Brazilian Journal of Pharmaceutical Sciences
http://creativecommons.org/licenses/by/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Copyright (c) 2020 Brazilian Journal of Pharmaceutical Sciences
http://creativecommons.org/licenses/by/4.0
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. 56 (2020); e17728
Brazilian Journal of Pharmaceutical Sciences; v. 56 (2020); e17728
Brazilian Journal of Pharmaceutical Sciences; Vol. 56 (2020); e17728
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
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