Development and validation of equilibrium dialysis UHPLC-MS/MS measurement procedures for total and unbound concentrations of bictegravir, dolutegravir, darunavir and doravirine in human plasma. Application to patients with HIV
Copyright © 2023 Elsevier B.V. All rights reserved..
BACKGROUND: Fixed-dose combinations of antiretroviral drugs are commonly used to treat HIV infection and therapeutic monitoring is not part of routine clinical practice. However, drug concentrations monitoring might have role in different clinical scenarios as well as for research purposes. This study aimed to develop and validate UHPLC-MS/MS procedures for measuring total and unbound concentrations of bictegravir, dolutegravir, darunavir and doravirine in human plasma.
MATERIAL AND METHODS: Equilibrium dialysis preceded sample preparation (based on protein precipitation) for measuring unbound antiretroviral concentrations. Chromatographic separations were achieved on an Acquity®-UPLC® HSS™-T3 column (50 mm × 2.1 mm; 1.8 µm) using a non-linear water/acetonitrile gradient containing 0.1 % formic acid at a 0.5 mL/min flow rate. Antiretrovirals were detected by tandem mass spectrometry in positive electrospray ionisation and multiple reaction monitoring modes.
RESULTS: No significant interferences or carry-over were observed. Imprecisions, absolute relative biases, normalised matrix effects and recoveries were ≤15.0 %, ≤11.1 %, (94.7-104.1)% and (96.7-105.5)%, respectively. Non-linear measuring intervals were observed between (25-10,000) µg/L for total/plasma dialysate concentrations and linearity schemes (1.00-100) µg/L for buffer dialysate concentrations.
CONCLUSIONS: The UHPLC-MS/MS procedures developed could be used for research purposes and therapeutic drug monitoring of antiretrovirals in routine clinical practice.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 2023 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:552 |
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| Enthalten in: |
Clinica chimica acta; international journal of clinical chemistry - 552(2023) vom: 01. Jan., Seite 117678 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Rigo-Bonnin, Raúl [VerfasserIn] |
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| Links: |
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| Themen: |
8GB79LOJ07 |
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| Anmerkungen: |
Date Completed 19.12.2023 Date Revised 19.12.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.cca.2023.117678 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM365334472 |
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| 100 | 1 | |a Rigo-Bonnin, Raúl |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Development and validation of equilibrium dialysis UHPLC-MS/MS measurement procedures for total and unbound concentrations of bictegravir, dolutegravir, darunavir and doravirine in human plasma. Application to patients with HIV |
| 264 | 1 | |c 2024 | |
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| 500 | |a Date Completed 19.12.2023 | ||
| 500 | |a Date Revised 19.12.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 Elsevier B.V. All rights reserved. | ||
| 520 | |a BACKGROUND: Fixed-dose combinations of antiretroviral drugs are commonly used to treat HIV infection and therapeutic monitoring is not part of routine clinical practice. However, drug concentrations monitoring might have role in different clinical scenarios as well as for research purposes. This study aimed to develop and validate UHPLC-MS/MS procedures for measuring total and unbound concentrations of bictegravir, dolutegravir, darunavir and doravirine in human plasma | ||
| 520 | |a MATERIAL AND METHODS: Equilibrium dialysis preceded sample preparation (based on protein precipitation) for measuring unbound antiretroviral concentrations. Chromatographic separations were achieved on an Acquity®-UPLC® HSS™-T3 column (50 mm × 2.1 mm; 1.8 µm) using a non-linear water/acetonitrile gradient containing 0.1 % formic acid at a 0.5 mL/min flow rate. Antiretrovirals were detected by tandem mass spectrometry in positive electrospray ionisation and multiple reaction monitoring modes | ||
| 520 | |a RESULTS: No significant interferences or carry-over were observed. Imprecisions, absolute relative biases, normalised matrix effects and recoveries were ≤15.0 %, ≤11.1 %, (94.7-104.1)% and (96.7-105.5)%, respectively. Non-linear measuring intervals were observed between (25-10,000) µg/L for total/plasma dialysate concentrations and linearity schemes (1.00-100) µg/L for buffer dialysate concentrations | ||
| 520 | |a CONCLUSIONS: The UHPLC-MS/MS procedures developed could be used for research purposes and therapeutic drug monitoring of antiretrovirals in routine clinical practice | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Bictegravir | |
| 650 | 4 | |a Darunavir | |
| 650 | 4 | |a Dolutegravir | |
| 650 | 4 | |a Doravirine | |
| 650 | 4 | |a Rapid equilibrium dialysis | |
| 650 | 4 | |a UHPLC-MS/MS | |
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| 650 | 7 | |a bictegravir |2 NLM | |
| 650 | 7 | |a 8GB79LOJ07 |2 NLM | |
| 650 | 7 | |a Dialysis Solutions |2 NLM | |
| 700 | 1 | |a García-Tejada, Laura |e verfasserin |4 aut | |
| 700 | 1 | |a Mas-Bosch, Virgínia |e verfasserin |4 aut | |
| 700 | 1 | |a Imaz, Arkaitz |e verfasserin |4 aut | |
| 700 | 1 | |a Manuel Tiraboschi, Juan |e verfasserin |4 aut | |
| 700 | 1 | |a Scévola, Sofía |e verfasserin |4 aut | |
| 700 | 1 | |a Niubó, Jordi |e verfasserin |4 aut | |
| 700 | 1 | |a Navarro-Alcaraz, Antonio |e verfasserin |4 aut | |
| 700 | 1 | |a Podzamczer, Daniel |e verfasserin |4 aut | |
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