| Literature DB >> 34100308 |
Jianghong Gu1, Jiang Wang1, Ashok Krishna2, Lin Xu2, Sharron Stewart2, Yan Wang3, Patrick J Faustino1, Diaa Shakleya1.
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.Entities:
Keywords: 6β-hydroxydexamethasone; UHPLC–MS/MS; aqueous humor; dexamethasone; plasma; rabbit; retina; validation; vitreous humor
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Year: 2021 PMID： 34100308 DOI： 10.4155/bio-2021-0088
Source DB: PubMed Journal: Bioanalysis ISSN： 1757-6180 Impact factor: 2.681