A Simple and Efficient HPLC Method for Benznidazole Dosage in Human Breast Milk

Background: Due to migration, Chagas disease is a significant public health problem in Latin America, and in other nonendemic regions. The 2 drugs currently available for the treatment, nifurtimox and benznidazole (BNZ), are associated with a high risk of toxicity in therapeutic doses. Excretion of...

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Autores principales: Marson, María Elena, Padró, Juan Manuel, Reta, Mario Roberto, Altcheh, Jaime, García Bournissen, Facundo, Mastrantonio Garrido, Guido Enrique
Formato: Articulo
Lenguaje:Inglés
Publicado: 2013
Materias:
Ciencias Médicas
breast milk
benznidazole
HPLC
Chagas disease
Acceso en línea:http://sedici.unlp.edu.ar/handle/10915/167268
Aporte de:
SEDICI (UNLP) de Universidad Nacional de La Plata
id I19-R120-10915-167268
record_format dspace
spelling I19-R120-10915-1672682024-06-15T04:08:10Z http://sedici.unlp.edu.ar/handle/10915/167268 A Simple and Efficient HPLC Method for Benznidazole Dosage in Human Breast Milk Marson, María Elena Padró, Juan Manuel Reta, Mario Roberto Altcheh, Jaime García Bournissen, Facundo Mastrantonio Garrido, Guido Enrique 2013-08 2024-06-14T14:54:04Z en Ciencias Médicas breast milk benznidazole HPLC Chagas disease Background: Due to migration, Chagas disease is a significant public health problem in Latin America, and in other nonendemic regions. The 2 drugs currently available for the treatment, nifurtimox and benznidazole (BNZ), are associated with a high risk of toxicity in therapeutic doses. Excretion of drug into human breast milk is a potential source of unwanted exposure and pharmacologic effects in the nursing infant. However, this phenomenon was not evaluated until now, and measurement techniques for both drugs in milk were not developed. Methods: In this work, we described the development of a simple and fast method to quantify BNZ in human milk using a pretreatment that involves acid protein precipitation followed by tandem microfiltration, and reverse phase high-performance liquid chromatography/ ultraviolet analysis. It is simple because it takes only 3 steps to obtain a clean extracted solution that is ready to inject into the highperformance liquid chromatography equipment. It is fast because a complete analysis of a sample takes only 36 minutes. Results: Although the human breast milk composition is very variable, and lipids are one of the most difficult compounds to clean up on a milk sample, the procedure has proven to be robust and sensitive with a limit of detection of 0.3 mg/mL and quantization of 0.9 mg/mL. Despite a 70% recovery value, which could be considered a relatively low result, this recovery is reproducible (coefficient of variation ,10%) and the analytical response under the linear range is very good (r2 = 0.9969 adjusted). Real samples of human breast milk from patients in treatment with BNZ were dosed to support the validation process of the method. Conclusions: The method described is fast, specific, accurate, precise, and sufficiently sensitive in the clinical context for the quantification of BNZ in human milk. For all these reasons, it is suitable for clinical risk evaluation studies. Facultad de Ciencias Médicas Articulo Articulo http://creativecommons.org/licenses/by-nc-sa/4.0/ Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0) application/pdf 522-526
institution Universidad Nacional de La Plata
institution_str I-19
repository_str R-120
collection SEDICI (UNLP)
language Inglés
topic Ciencias Médicas
breast milk
benznidazole
HPLC
Chagas disease
spellingShingle Ciencias Médicas
breast milk
benznidazole
HPLC
Chagas disease
Marson, María Elena
Padró, Juan Manuel
Reta, Mario Roberto
Altcheh, Jaime
García Bournissen, Facundo
Mastrantonio Garrido, Guido Enrique
A Simple and Efficient HPLC Method for Benznidazole Dosage in Human Breast Milk
topic_facet Ciencias Médicas
breast milk
benznidazole
HPLC
Chagas disease
description Background: Due to migration, Chagas disease is a significant public health problem in Latin America, and in other nonendemic regions. The 2 drugs currently available for the treatment, nifurtimox and benznidazole (BNZ), are associated with a high risk of toxicity in therapeutic doses. Excretion of drug into human breast milk is a potential source of unwanted exposure and pharmacologic effects in the nursing infant. However, this phenomenon was not evaluated until now, and measurement techniques for both drugs in milk were not developed. Methods: In this work, we described the development of a simple and fast method to quantify BNZ in human milk using a pretreatment that involves acid protein precipitation followed by tandem microfiltration, and reverse phase high-performance liquid chromatography/ ultraviolet analysis. It is simple because it takes only 3 steps to obtain a clean extracted solution that is ready to inject into the highperformance liquid chromatography equipment. It is fast because a complete analysis of a sample takes only 36 minutes. Results: Although the human breast milk composition is very variable, and lipids are one of the most difficult compounds to clean up on a milk sample, the procedure has proven to be robust and sensitive with a limit of detection of 0.3 mg/mL and quantization of 0.9 mg/mL. Despite a 70% recovery value, which could be considered a relatively low result, this recovery is reproducible (coefficient of variation ,10%) and the analytical response under the linear range is very good (r2 = 0.9969 adjusted). Real samples of human breast milk from patients in treatment with BNZ were dosed to support the validation process of the method. Conclusions: The method described is fast, specific, accurate, precise, and sufficiently sensitive in the clinical context for the quantification of BNZ in human milk. For all these reasons, it is suitable for clinical risk evaluation studies.
format Articulo
Articulo
author Marson, María Elena
Padró, Juan Manuel
Reta, Mario Roberto
Altcheh, Jaime
García Bournissen, Facundo
Mastrantonio Garrido, Guido Enrique
author_facet Marson, María Elena
Padró, Juan Manuel
Reta, Mario Roberto
Altcheh, Jaime
García Bournissen, Facundo
Mastrantonio Garrido, Guido Enrique
author_sort Marson, María Elena
title A Simple and Efficient HPLC Method for Benznidazole Dosage in Human Breast Milk
title_short A Simple and Efficient HPLC Method for Benznidazole Dosage in Human Breast Milk
title_full A Simple and Efficient HPLC Method for Benznidazole Dosage in Human Breast Milk
title_fullStr A Simple and Efficient HPLC Method for Benznidazole Dosage in Human Breast Milk
title_full_unstemmed A Simple and Efficient HPLC Method for Benznidazole Dosage in Human Breast Milk
title_sort simple and efficient hplc method for benznidazole dosage in human breast milk
publishDate 2013
url http://sedici.unlp.edu.ar/handle/10915/167268
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