Development and validation of an HPLC-UV method for accelerated stability study and pharmacokinetic analysis of venlafaxine
Autor(a) principal: | |
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Data de Publicação: | 2020 |
Outros Autores: | , , , |
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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Brazilian Journal of Pharmaceutical Sciences |
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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 |
_version_ |
1800222915051913216 |