Comparison of Various Chromatographic Systems for Identification of Vortioxetine in Bulk Drug Substance, Human Serum, Saliva, and Urine Samples by HPLC-DAD and LC-QTOF-MS

<i>Background</i>: Determination of psychotropic drugs in clinical study is significant, and the establishment of methodologies for these drugs in biological matrices is essential for patients’ safety. The search for new methods for their detection is one of the most important challenges...

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Main Authors: Anna Petruczynik, Karol Wróblewski, Krzysztof Wojtanowski, Tomasz Mroczek, Dariusz Juchnowicz, Hanna Karakuła-Juchnowicz, Tomasz Tuzimski
Format: Article
Language:English
Published: MDPI AG 2020-05-01
Series:Molecules
Subjects:
Online Access:https://www.mdpi.com/1420-3049/25/11/2483
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author Anna Petruczynik
Karol Wróblewski
Krzysztof Wojtanowski
Tomasz Mroczek
Dariusz Juchnowicz
Hanna Karakuła-Juchnowicz
Tomasz Tuzimski
author_facet Anna Petruczynik
Karol Wróblewski
Krzysztof Wojtanowski
Tomasz Mroczek
Dariusz Juchnowicz
Hanna Karakuła-Juchnowicz
Tomasz Tuzimski
author_sort Anna Petruczynik
collection DOAJ
description <i>Background</i>: Determination of psychotropic drugs in clinical study is significant, and the establishment of methodologies for these drugs in biological matrices is essential for patients’ safety. The search for new methods for their detection is one of the most important challenges of modern scientific research. The methods for analyzing of psychotropic drugs and their metabolites in different biological samples should be based on combining a very efficient separation technique including high-performance liquid chromatography (HPLC), with a sensitive detection method and effectively sample preparation methods. <i>Objective</i>: Retention, peaks symmetry and system efficiency of vortioxetine on Hydro RP, Polar RP, HILIC A (with silica stationary phase), HILIC-B (with aminopropyl stationary phase), and ACE HILIC-N (with polyhydroxy stationary phase and SCX columns were investigated. Various mobile phases containing methanol or acetonitrile as organic modifiers and different additives were also applied to obtained optimal retention, peaks shape, and systems efficiency. The best chromatographic procedure was used for simultaneous analysis of vortioxetine and its metabolites in human serum, urine and saliva samples. <i>Methods</i>: Analysis of vortioxetine was performed in various chromatographic systems: Reversed phase (RP) systems on alkylbonded or phenyl stationary phases, hydrophilic interaction liquid chromatography (HILIC), and ion-exchange chromatography (IEC). Based on the dependence of log <i>k</i> vs the concentration of the organic modifier, log <i>kw</i> values for vortioxetine in various chromatographic systems were determined and compared with calculated log <i>P</i> values. Solid phase extraction (SPE) method was applied for sample pre-treatment before HPLC analysis. HPLC-QTOF-MS method was applied for confirmation of presence of vortioxetine and some its metabolites in biological samples collected from psychiatric patient. <i>Conclusions</i>: Differences were observed in retention parameters with a change of the applied chromatographic system. The various properties of stationary phases resulted in differences in vortioxetine retention, systems’ efficiency, and peaks’ shape. Lipophilicity parameters were also determined using different HPLC conditions. The most optimal systems were chosen for the analysis of vortioxetine in biological samples. Both serum and urine or saliva samples collected from patients treated with vortioxetine can be used for the drug determination. For the first time, vortioxetine was detected in patient’s saliva. Obtained results indicate on possibility of application of saliva samples, which collection are non-invasive and painless, for determination and therapeutic drug monitoring in patients.
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spelling doaj.art-e168bfc08dec4c3a8545b1957bdb72dd2023-11-20T01:54:09ZengMDPI AGMolecules1420-30492020-05-012511248310.3390/molecules25112483Comparison of Various Chromatographic Systems for Identification of Vortioxetine in Bulk Drug Substance, Human Serum, Saliva, and Urine Samples by HPLC-DAD and LC-QTOF-MSAnna Petruczynik0Karol Wróblewski1Krzysztof Wojtanowski2Tomasz Mroczek3Dariusz Juchnowicz4Hanna Karakuła-Juchnowicz5Tomasz Tuzimski6Department of Inorganic Chemistry, Medical University of Lublin, Chodźki 4a, 20-093 Lublin, PolandDepartment of Experimental and Clinical Pharmacology, University of Rzeszów, Kopisto 2a, 35-959 Rzeszów, PolandDepartment of Pharmacognosy with Medicinal Plant Unit, Medical University of Lublin, Chodźki 1, 20-093 Lublin, PolandDepartment of Pharmacognosy with Medicinal Plant Unit, Medical University of Lublin, Chodźki 1, 20-093 Lublin, PolandDepartment of Psychiatric Nursing, Medical University of Lublin, Chodźki 7, 20-124 Lublin, Poland1st Department of Psychiatry, Psychotherapy and Early Intervention, Medical University of Lublin, Głuska 1, 20-439 Lublin, PolandDepartment of Physical Chemistry, Medical University of Lublin, Chodźki 4a, 20-093 Lublin, Poland<i>Background</i>: Determination of psychotropic drugs in clinical study is significant, and the establishment of methodologies for these drugs in biological matrices is essential for patients’ safety. The search for new methods for their detection is one of the most important challenges of modern scientific research. The methods for analyzing of psychotropic drugs and their metabolites in different biological samples should be based on combining a very efficient separation technique including high-performance liquid chromatography (HPLC), with a sensitive detection method and effectively sample preparation methods. <i>Objective</i>: Retention, peaks symmetry and system efficiency of vortioxetine on Hydro RP, Polar RP, HILIC A (with silica stationary phase), HILIC-B (with aminopropyl stationary phase), and ACE HILIC-N (with polyhydroxy stationary phase and SCX columns were investigated. Various mobile phases containing methanol or acetonitrile as organic modifiers and different additives were also applied to obtained optimal retention, peaks shape, and systems efficiency. The best chromatographic procedure was used for simultaneous analysis of vortioxetine and its metabolites in human serum, urine and saliva samples. <i>Methods</i>: Analysis of vortioxetine was performed in various chromatographic systems: Reversed phase (RP) systems on alkylbonded or phenyl stationary phases, hydrophilic interaction liquid chromatography (HILIC), and ion-exchange chromatography (IEC). Based on the dependence of log <i>k</i> vs the concentration of the organic modifier, log <i>kw</i> values for vortioxetine in various chromatographic systems were determined and compared with calculated log <i>P</i> values. Solid phase extraction (SPE) method was applied for sample pre-treatment before HPLC analysis. HPLC-QTOF-MS method was applied for confirmation of presence of vortioxetine and some its metabolites in biological samples collected from psychiatric patient. <i>Conclusions</i>: Differences were observed in retention parameters with a change of the applied chromatographic system. The various properties of stationary phases resulted in differences in vortioxetine retention, systems’ efficiency, and peaks’ shape. Lipophilicity parameters were also determined using different HPLC conditions. The most optimal systems were chosen for the analysis of vortioxetine in biological samples. Both serum and urine or saliva samples collected from patients treated with vortioxetine can be used for the drug determination. For the first time, vortioxetine was detected in patient’s saliva. Obtained results indicate on possibility of application of saliva samples, which collection are non-invasive and painless, for determination and therapeutic drug monitoring in patients.https://www.mdpi.com/1420-3049/25/11/2483vortioxetineHPLC-DADHPLC-QTOF-MSSPEsalivaserum
spellingShingle Anna Petruczynik
Karol Wróblewski
Krzysztof Wojtanowski
Tomasz Mroczek
Dariusz Juchnowicz
Hanna Karakuła-Juchnowicz
Tomasz Tuzimski
Comparison of Various Chromatographic Systems for Identification of Vortioxetine in Bulk Drug Substance, Human Serum, Saliva, and Urine Samples by HPLC-DAD and LC-QTOF-MS
Molecules
vortioxetine
HPLC-DAD
HPLC-QTOF-MS
SPE
saliva
serum
title Comparison of Various Chromatographic Systems for Identification of Vortioxetine in Bulk Drug Substance, Human Serum, Saliva, and Urine Samples by HPLC-DAD and LC-QTOF-MS
title_full Comparison of Various Chromatographic Systems for Identification of Vortioxetine in Bulk Drug Substance, Human Serum, Saliva, and Urine Samples by HPLC-DAD and LC-QTOF-MS
title_fullStr Comparison of Various Chromatographic Systems for Identification of Vortioxetine in Bulk Drug Substance, Human Serum, Saliva, and Urine Samples by HPLC-DAD and LC-QTOF-MS
title_full_unstemmed Comparison of Various Chromatographic Systems for Identification of Vortioxetine in Bulk Drug Substance, Human Serum, Saliva, and Urine Samples by HPLC-DAD and LC-QTOF-MS
title_short Comparison of Various Chromatographic Systems for Identification of Vortioxetine in Bulk Drug Substance, Human Serum, Saliva, and Urine Samples by HPLC-DAD and LC-QTOF-MS
title_sort comparison of various chromatographic systems for identification of vortioxetine in bulk drug substance human serum saliva and urine samples by hplc dad and lc qtof ms
topic vortioxetine
HPLC-DAD
HPLC-QTOF-MS
SPE
saliva
serum
url https://www.mdpi.com/1420-3049/25/11/2483
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