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Vigabatrin in dried plasma spots: Validation of a novel LC-MS/MS method and application to clinical practice

Authorized Users Only
2014
Authors
Kostić, Nada
Dotsikas, Yannis
Jović, Nebojša
Stevanović, Galina
Malenović, Anđelija
Medenica, Mirjana
Article (Published version)
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Abstract
This paper presents a LC-MS/MS method for the determination of antiepileptic drug vigabatrin in dried plasma spots (DPS). Due to its zwitterionic chemical structure, a pre-column derivatization procedure was performed, aiming to yield enhanced ionization efficiency and improved chromatographic behaviour. Propyl chloroformate, in the presence of propanol, was selected as the best derivatization reagent, providing a strong signal along with reasonable run time. A relatively novel sample collection technique, DPS, was utilized, offering easy sample handling and analysis, using a sample in micro amount (similar to 5 mu L). Derivatized vigabatrin and its internal standard, 4-aminocyclohexanecarboxylic acid, were extracted by liquid-liquid extraction (LLE) and determined in positive ion mode by applying two SRM transitions per analyte. A Zorbax Eclipse XDB-C8 column (150 x 4.6 mm, 5 mu m particle size) maintained at 30 degrees C, was utilized with running mobile phase composed of acetonitril...e: 0.15% formic acid (85:15, v/v). Flow rate was 550 mu L/min and total run time 4.5 min. The assay exhibited excellent linearity over the concentration range of 0.500-50.0 mu g/mL, which is suitable for the determination of vigabatrin level after per os administration in children and youths with epilepsy, who were on vigabatrin therapy, with or without co-medication. Specificity, accuracy, precision, recovery, matrix-effect and stability were also estimated and assessed within acceptance criteria.

Keywords:
Vigabatrin / Chloroformates / Dried plasma spots / Mass spectrometry
Source:
Journal of Chromatography B-Analytical Technologies in the Biomedical and Life Sciences, 2014, 962, 102-108
Publisher:
  • Elsevier Science BV, Amsterdam
Funding / projects:
  • Modelling of different chromatographic systems with chemometrical approach in pharmaceutical analysis (RS-172052)

DOI: 10.1016/j.jchromb.2014.05.037

ISSN: 1570-0232

PubMed: 24908379

WoS: 000338406800015

Scopus: 2-s2.0-84902007536
[ Google Scholar ]
11
10
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/2212
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - JOUR
AU  - Kostić, Nada
AU  - Dotsikas, Yannis
AU  - Jović, Nebojša
AU  - Stevanović, Galina
AU  - Malenović, Anđelija
AU  - Medenica, Mirjana
PY  - 2014
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2212
AB  - This paper presents a LC-MS/MS method for the determination of antiepileptic drug vigabatrin in dried plasma spots (DPS). Due to its zwitterionic chemical structure, a pre-column derivatization procedure was performed, aiming to yield enhanced ionization efficiency and improved chromatographic behaviour. Propyl chloroformate, in the presence of propanol, was selected as the best derivatization reagent, providing a strong signal along with reasonable run time. A relatively novel sample collection technique, DPS, was utilized, offering easy sample handling and analysis, using a sample in micro amount (similar to 5 mu L). Derivatized vigabatrin and its internal standard, 4-aminocyclohexanecarboxylic acid, were extracted by liquid-liquid extraction (LLE) and determined in positive ion mode by applying two SRM transitions per analyte. A Zorbax Eclipse XDB-C8 column (150 x 4.6 mm, 5 mu m particle size) maintained at 30 degrees C, was utilized with running mobile phase composed of acetonitrile: 0.15% formic acid (85:15, v/v). Flow rate was 550 mu L/min and total run time 4.5 min. The assay exhibited excellent linearity over the concentration range of 0.500-50.0 mu g/mL, which is suitable for the determination of vigabatrin level after per os administration in children and youths with epilepsy, who were on vigabatrin therapy, with or without co-medication. Specificity, accuracy, precision, recovery, matrix-effect and stability were also estimated and assessed within acceptance criteria.
PB  - Elsevier Science BV, Amsterdam
T2  - Journal of Chromatography B-Analytical Technologies in the Biomedical and Life Sciences
T1  - Vigabatrin in dried plasma spots: Validation of a novel LC-MS/MS method and application to clinical practice
VL  - 962
SP  - 102
EP  - 108
DO  - 10.1016/j.jchromb.2014.05.037
ER  - 
@article{
author = "Kostić, Nada and Dotsikas, Yannis and Jović, Nebojša and Stevanović, Galina and Malenović, Anđelija and Medenica, Mirjana",
year = "2014",
abstract = "This paper presents a LC-MS/MS method for the determination of antiepileptic drug vigabatrin in dried plasma spots (DPS). Due to its zwitterionic chemical structure, a pre-column derivatization procedure was performed, aiming to yield enhanced ionization efficiency and improved chromatographic behaviour. Propyl chloroformate, in the presence of propanol, was selected as the best derivatization reagent, providing a strong signal along with reasonable run time. A relatively novel sample collection technique, DPS, was utilized, offering easy sample handling and analysis, using a sample in micro amount (similar to 5 mu L). Derivatized vigabatrin and its internal standard, 4-aminocyclohexanecarboxylic acid, were extracted by liquid-liquid extraction (LLE) and determined in positive ion mode by applying two SRM transitions per analyte. A Zorbax Eclipse XDB-C8 column (150 x 4.6 mm, 5 mu m particle size) maintained at 30 degrees C, was utilized with running mobile phase composed of acetonitrile: 0.15% formic acid (85:15, v/v). Flow rate was 550 mu L/min and total run time 4.5 min. The assay exhibited excellent linearity over the concentration range of 0.500-50.0 mu g/mL, which is suitable for the determination of vigabatrin level after per os administration in children and youths with epilepsy, who were on vigabatrin therapy, with or without co-medication. Specificity, accuracy, precision, recovery, matrix-effect and stability were also estimated and assessed within acceptance criteria.",
publisher = "Elsevier Science BV, Amsterdam",
journal = "Journal of Chromatography B-Analytical Technologies in the Biomedical and Life Sciences",
title = "Vigabatrin in dried plasma spots: Validation of a novel LC-MS/MS method and application to clinical practice",
volume = "962",
pages = "102-108",
doi = "10.1016/j.jchromb.2014.05.037"
}
Kostić, N., Dotsikas, Y., Jović, N., Stevanović, G., Malenović, A.,& Medenica, M.. (2014). Vigabatrin in dried plasma spots: Validation of a novel LC-MS/MS method and application to clinical practice. in Journal of Chromatography B-Analytical Technologies in the Biomedical and Life Sciences
Elsevier Science BV, Amsterdam., 962, 102-108.
https://doi.org/10.1016/j.jchromb.2014.05.037
Kostić N, Dotsikas Y, Jović N, Stevanović G, Malenović A, Medenica M. Vigabatrin in dried plasma spots: Validation of a novel LC-MS/MS method and application to clinical practice. in Journal of Chromatography B-Analytical Technologies in the Biomedical and Life Sciences. 2014;962:102-108.
doi:10.1016/j.jchromb.2014.05.037 .
Kostić, Nada, Dotsikas, Yannis, Jović, Nebojša, Stevanović, Galina, Malenović, Anđelija, Medenica, Mirjana, "Vigabatrin in dried plasma spots: Validation of a novel LC-MS/MS method and application to clinical practice" in Journal of Chromatography B-Analytical Technologies in the Biomedical and Life Sciences, 962 (2014):102-108,
https://doi.org/10.1016/j.jchromb.2014.05.037 . .

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