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Quantitation of pregabalin in dried blood spots and dried plasma spots by validated LC-MS/MS methods

Authorized Users Only
2015
Authors
Kostić, Nada
Dotsikas, Yannis
Jović, Nebojša
Stevanović, Galina
Malenović, Anđelija
Medenica, Mirjana
Article (Published version)
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Abstract
In this paper, novel LC-MS/MS methods for the determination of antiepileptic drug pregabalin in dried matrix spots (DMS) are presented. This attractive technique of sample collection in micro amount was utilized in the form of dried blood spots (DBS) and dried plasma spots (DPS). Following a pre-column derivatization procedure, using n-propyl chloroformate in the presence of n-propanol, and consecutive liquid-liquid extraction, derivatized pregabalin and its internal standard, 4-aminocyclohexanecarboxylic acid, were detected in positive ion mode by applying two SRM transitions per analyte. A YMC-Pack Octyl column (50 mm x 4.0 mm, 3 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 2 min. Established methods were fully validated over the concentration range of 0.200-20.0 mu g/mL for DBS and 0.400-40.0 mu g/mL for DPS, respectively, while specificit...y, accuracy, precision, recovery, matrix-effect, stability, dilution integrity and spot homogeneity were found within acceptance criteria. Validated methods were applied for the determination of pregabalin levels in dried blood and plasma samples obtained from patients with epilepsy, after per os administration of commercial capsules. Comparison of drug level in blood and plasma, as well as correction steps undertaken in order to overcome hematocrit issue, when analyzing DBS, are also given.

Keywords:
Pregabalin / Chloroformates / Dried blood/plasma spots / Mass spectrometry / Hematocrit
Source:
Journal of Pharmaceutical and Biomedical Analysis, 2015, 109, 79-84
Publisher:
  • Elsevier Science BV, Amsterdam
Funding / projects:
  • Modelling of different chromatographic systems with chemometrical approach in pharmaceutical analysis (RS-172052)

DOI: 10.1016/j.jpba.2015.02.023

ISSN: 0731-7085

PubMed: 25767905

WoS: 000353078700011

Scopus: 2-s2.0-84924370331
[ Google Scholar ]
32
31
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/2410
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  - 2015
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2410
AB  - In this paper, novel LC-MS/MS methods for the determination of antiepileptic drug pregabalin in dried matrix spots (DMS) are presented. This attractive technique of sample collection in micro amount was utilized in the form of dried blood spots (DBS) and dried plasma spots (DPS). Following a pre-column derivatization procedure, using n-propyl chloroformate in the presence of n-propanol, and consecutive liquid-liquid extraction, derivatized pregabalin and its internal standard, 4-aminocyclohexanecarboxylic acid, were detected in positive ion mode by applying two SRM transitions per analyte. A YMC-Pack Octyl column (50 mm x 4.0 mm, 3 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 2 min. Established methods were fully validated over the concentration range of 0.200-20.0 mu g/mL for DBS and 0.400-40.0 mu g/mL for DPS, respectively, while specificity, accuracy, precision, recovery, matrix-effect, stability, dilution integrity and spot homogeneity were found within acceptance criteria. Validated methods were applied for the determination of pregabalin levels in dried blood and plasma samples obtained from patients with epilepsy, after per os administration of commercial capsules. Comparison of drug level in blood and plasma, as well as correction steps undertaken in order to overcome hematocrit issue, when analyzing DBS, are also given.
PB  - Elsevier Science BV, Amsterdam
T2  - Journal of Pharmaceutical and Biomedical Analysis
T1  - Quantitation of pregabalin in dried blood spots and dried plasma spots by validated LC-MS/MS methods
VL  - 109
SP  - 79
EP  - 84
DO  - 10.1016/j.jpba.2015.02.023
ER  - 
@article{
author = "Kostić, Nada and Dotsikas, Yannis and Jović, Nebojša and Stevanović, Galina and Malenović, Anđelija and Medenica, Mirjana",
year = "2015",
abstract = "In this paper, novel LC-MS/MS methods for the determination of antiepileptic drug pregabalin in dried matrix spots (DMS) are presented. This attractive technique of sample collection in micro amount was utilized in the form of dried blood spots (DBS) and dried plasma spots (DPS). Following a pre-column derivatization procedure, using n-propyl chloroformate in the presence of n-propanol, and consecutive liquid-liquid extraction, derivatized pregabalin and its internal standard, 4-aminocyclohexanecarboxylic acid, were detected in positive ion mode by applying two SRM transitions per analyte. A YMC-Pack Octyl column (50 mm x 4.0 mm, 3 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 2 min. Established methods were fully validated over the concentration range of 0.200-20.0 mu g/mL for DBS and 0.400-40.0 mu g/mL for DPS, respectively, while specificity, accuracy, precision, recovery, matrix-effect, stability, dilution integrity and spot homogeneity were found within acceptance criteria. Validated methods were applied for the determination of pregabalin levels in dried blood and plasma samples obtained from patients with epilepsy, after per os administration of commercial capsules. Comparison of drug level in blood and plasma, as well as correction steps undertaken in order to overcome hematocrit issue, when analyzing DBS, are also given.",
publisher = "Elsevier Science BV, Amsterdam",
journal = "Journal of Pharmaceutical and Biomedical Analysis",
title = "Quantitation of pregabalin in dried blood spots and dried plasma spots by validated LC-MS/MS methods",
volume = "109",
pages = "79-84",
doi = "10.1016/j.jpba.2015.02.023"
}
Kostić, N., Dotsikas, Y., Jović, N., Stevanović, G., Malenović, A.,& Medenica, M.. (2015). Quantitation of pregabalin in dried blood spots and dried plasma spots by validated LC-MS/MS methods. in Journal of Pharmaceutical and Biomedical Analysis
Elsevier Science BV, Amsterdam., 109, 79-84.
https://doi.org/10.1016/j.jpba.2015.02.023
Kostić N, Dotsikas Y, Jović N, Stevanović G, Malenović A, Medenica M. Quantitation of pregabalin in dried blood spots and dried plasma spots by validated LC-MS/MS methods. in Journal of Pharmaceutical and Biomedical Analysis. 2015;109:79-84.
doi:10.1016/j.jpba.2015.02.023 .
Kostić, Nada, Dotsikas, Yannis, Jović, Nebojša, Stevanović, Galina, Malenović, Anđelija, Medenica, Mirjana, "Quantitation of pregabalin in dried blood spots and dried plasma spots by validated LC-MS/MS methods" in Journal of Pharmaceutical and Biomedical Analysis, 109 (2015):79-84,
https://doi.org/10.1016/j.jpba.2015.02.023 . .

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