Simultaneous quantification of dexamethasone and 6β-hydroxydexamethasone in rabbit plasma, aqueous and vitreous humor, and retina by UHPLC

Simultaneous quantification of dexamethasone and 6β-hydroxydexamethasone in rabbit plasma, aqueous and vitreous humor, and retina by UHPLC–MS/MS

Published:2021-07 Issue:13 Volume:13 Page:1051-1062
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Gu Jianghong¹,Wang Jiang¹,Krishna Ashok²,Xu Lin²,Stewart Sharron²,Wang Yan³,Faustino Patrick J¹,Shakleya Diaa¹^ORCID

Affiliation:

1. Division of Product Quality Research, Office of Testing & Research, Office of Pharmaceutical Quality, US Food & Drug Administration, 10903 New Hampshire Ave., Life Sciences Building 64, Silver Spring, MD 20993, USA

2. Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, US Food & Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA

3. Division of Therapeutic Performance, Office of Research & Standards, Office of Generic Drugs, Center for Drug Evaluation & Research, US Food & Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA

Abstract

Aim: To develop and validate a fit for purpose method for the simultaneous determination of dexamethasone and its major metabolite, 6β-hydroxydexamethasone, in rabbit plasma and ocular matrices to measure the in vivo release and distribution profile of dexamethasone from intravitreal implants. Materials & methods: An UHPLC–MS/MS system was employed to perform the bioanalysis. The method was validated according to the US FDA Bioanalytical Method Validation Guidance for Industry. Results & conclusion: The method was found to be fit-for-purpose for the described biological matrices and had a LLOQ of 0.1 ng/ml.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Link

https://www.future-science.com/doi/pdf/10.4155/bio-2021-0088

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