LC-MS/MS method for simultaneous quantification of dexamethasone and tobramycin in rabbit ocular biofluids
Copyright © 2021 Elsevier B.V. All rights reserved..
The complexity of Tobradex® ointment formulation (dexamethasone 0.1 wt% and tobramycin 0.3 wt%) and the high cost of pharmacokinetic (PK) studies in human aqueous humor may prevent generic drug companies from moving forward with a Tobradex®-equivalent product development. The in vitro drug release test would be an alternative approach for differentiating the generic formulations containing both dexamethasone (DEX) and tobramycin (TOB), and the results should be correlated with the in vivo ocular PK studies for further evaluation. To facilitate the in vivo ocular PK studies, a sensitive, rapid and specific liquid chromatography-tandem mass spectrometry (LC-MS/MS) method that can simultaneously quantify both DEX and TOB in rabbit ocular matrices including tear, aqueous humor and cornea was established and validated. The lower limit of quantification (LLOQ) was 1.5 ng/ml for DEX and 3 ng/ml for TOB with good precision and accuracy. Both intra- and inter-batch precisions were within ±15%, and the accuracy for all QCs was within the range of 85-115%. This new method was successfully applied for a pilot pharmacokinetic analysis of DEX and TOB in rabbit tears after topical administration of Tobradex® ointment.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:1170 |
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| Enthalten in: |
Journal of chromatography. B, Analytical technologies in the biomedical and life sciences - 1170(2021) vom: 30. Apr., Seite 122610 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Meng, Tuo [VerfasserIn] |
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| Links: |
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| Themen: |
7S5I7G3JQL |
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| Anmerkungen: |
Date Completed 18.06.2021 Date Revised 01.05.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.jchromb.2021.122610 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM32270765X |
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| 245 | 1 | 0 | |a LC-MS/MS method for simultaneous quantification of dexamethasone and tobramycin in rabbit ocular biofluids |
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| 520 | |a Copyright © 2021 Elsevier B.V. All rights reserved. | ||
| 520 | |a The complexity of Tobradex® ointment formulation (dexamethasone 0.1 wt% and tobramycin 0.3 wt%) and the high cost of pharmacokinetic (PK) studies in human aqueous humor may prevent generic drug companies from moving forward with a Tobradex®-equivalent product development. The in vitro drug release test would be an alternative approach for differentiating the generic formulations containing both dexamethasone (DEX) and tobramycin (TOB), and the results should be correlated with the in vivo ocular PK studies for further evaluation. To facilitate the in vivo ocular PK studies, a sensitive, rapid and specific liquid chromatography-tandem mass spectrometry (LC-MS/MS) method that can simultaneously quantify both DEX and TOB in rabbit ocular matrices including tear, aqueous humor and cornea was established and validated. The lower limit of quantification (LLOQ) was 1.5 ng/ml for DEX and 3 ng/ml for TOB with good precision and accuracy. Both intra- and inter-batch precisions were within ±15%, and the accuracy for all QCs was within the range of 85-115%. This new method was successfully applied for a pilot pharmacokinetic analysis of DEX and TOB in rabbit tears after topical administration of Tobradex® ointment | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Antibiotics | |
| 650 | 4 | |a Corticosteroid | |
| 650 | 4 | |a LC-MS/MS | |
| 650 | 4 | |a Ocular pharmacokinetics | |
| 650 | 4 | |a Ophthalmic ointment | |
| 650 | 7 | |a Anti-Bacterial Agents |2 NLM | |
| 650 | 7 | |a Dexamethasone |2 NLM | |
| 650 | 7 | |a 7S5I7G3JQL |2 NLM | |
| 650 | 7 | |a Tobramycin |2 NLM | |
| 650 | 7 | |a VZ8RRZ51VK |2 NLM | |
| 700 | 1 | |a Kosmider, Leon |e verfasserin |4 aut | |
| 700 | 1 | |a Chai, Guihong |e verfasserin |4 aut | |
| 700 | 1 | |a Moothedathu Raynold, Aji Alex |e verfasserin |4 aut | |
| 700 | 1 | |a Pearcy, Adam C |e verfasserin |4 aut | |
| 700 | 1 | |a Qin, Bin |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Yan |e verfasserin |4 aut | |
| 700 | 1 | |a Lu, Xiuling |e verfasserin |4 aut | |
| 700 | 1 | |a Halquist, Matthew S |e verfasserin |4 aut | |
| 700 | 1 | |a Xu, Qingguo |e verfasserin |4 aut | |
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