Validation of Direct Method to Quantify Dexamethasone in Human Aqueous Humor by LC–MS/MS

Ferreira, Mônica Siqueira; Marquez, Cláudio Roberto; Santos, Danieli Almeida Dos; Gabbai, José Jorge; Martho, Aline Cristina; Brandão, Amanda Hayashi Yamanouchi; Barella, Kleyton Arlindo; Riccio, Maria Francesca; Noboli, Ana Cláudia; Júnior, Pedro S Carvalho

doi:10.4155/bio-2018-0079

Cited by 8 publications

(5 citation statements)

References 30 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The final concentrations of dexamethasone were 0, 2.5, 5, 25, 50, and 100 ng mL −1 . [43][44][45] In Vivo Study: All the animal experiments were carried out following the guide approved by the Institutional Animal Care and Use Committee (IACUC) of Shanghai Institute of Materia Medica, Chinese Academy of Sciences (CAS). Rabbits weighing 2.0-2.5 kg, free of any sign of ocular inflammation or gross abnormalities, were provided by the Shanghai Laboratory Animal Center, CAS, Shanghai, China (IACUC Application number 2017-08-ZJW-15).…”

Section: Hplc and Lc-ms/ms Methods Validationmentioning

confidence: 99%

Facile Synthesis and Size Control of 2D Cyclodextrin‐Based Metal–Organic Frameworks Nanosheet for Topical Drug Delivery

Bello

Yang

Wang

et al. 2020

Part & Part Syst Charact

View full text Add to dashboard Cite

carrier system is delivering the active ingredient(s) to the target site of action in a safe, effective and efficient way to elicit its pharmacological effect. [1,2] Precisely, the drug should arrive at the disease site at the right time in a controlled manner. Topical eye formulations are the most convenient and accepted ocular delivery systems for treating eye diseases accounting for up to 90% of ophthalmic medicines. [3] However, only 5% of the instilled dose penetrates into the deeper ocular tissues while the larger percentage gets lost through rapid eye blinking, tear turnover, and nasolacrimal drainage. Hence, making it extremely difficult to achieve therapeutic drug concentration following topical eye instillation. [4] To overcome these challenges, numerous works have been reported in the literature and various strategies implemented to improve ocular bioavailability and retention time. [5-7] Several formulations and novel carrier systems have been designed, for example, in situ forming gel system, [8,9] microemulsions, [10,11] and liposomes, [12,13] which are specifically designed to achieve favorable residence time and sustained drug release. Though the use of these technologies has opened the door for more specific and targeted delivery systems, the number of the novel ocular products entering into the market is very slow In this work, a 2D nanosheet (NS) of γ-cyclodextrin (CD)-based metalorganic frameworks (MOFs) is synthesized through a facile green chemistry approach. NS-MOF carrier is constructed using a water system in a simple one-pot reaction involving CD and potassium carbonate. Particle size optimization is achieved by adjusting the reaction temperature and the introduction of crystal growth suppressor (appropriate proportion of acetone). The NS-MOF stability in aqueous medium is improved by polymerization reaction of crosslinked CD-MOF (CL-CD-MOF) without blocking its cavity for drug loading. The effects of particle geometry and size of nanoporous materials on their pharmacokinetics during drug delivery are compared between the sheetlike DXM@CL-NS-MOF and 3D-cubic-shaped DXM@CL-CD-MOF loaded with the same quantity of dexamethasone (DXM). The bioefficiency of these carriers in tear fluids and aqueous humors to deliver DXM is investigated in vivo. The results demonstrate that the 2D-nanosheet particles significantly improve precorneal residence time and intraocular bioavailability over the commercial Maxidex (0.1% dexamethasone) and its 3D-cubes counterpart of similar chemical composition. It suggests that the geometry of a carrier play a significant role in the biodistribution, and the carrier of CL-NS-MOF is a good candidate for ocular drug delivery.

show abstract

Section: Hplc and Lc-ms/ms Methods Validationmentioning

confidence: 99%

Facile Synthesis and Size Control of 2D Cyclodextrin‐Based Metal–Organic Frameworks Nanosheet for Topical Drug Delivery

Bello

Yang

Wang

et al. 2020

Part & Part Syst Charact

View full text Add to dashboard Cite

show abstract

“…Ofloxacin (OFX) is a broad-spectrum antibiotic highly efficient against gram-negative and positive bacteria and is extensively used for the treatment of local ocular infections in humans and animals [5,6]. Dexamethasone (DEX) is a glucocorticoid derivative having potential anti-inflammatory activity mostly used in severe ocular diseases, such as inflammatory conditions, lymphomas, shock, and allergic reactions [7]. Multiple scientific communications describing analytical and bioanalytical methods for estimation of individual drugs using HPLC or LC-MS/MS in pharmaceutical dosage forms, biological matrices [8][9][10], aqueous humor, and cornea [11,12] are available in the literature.…”

Section: Bacterial Keratitis (Bk) Involves Corneal Inflammation Arisi...mentioning

confidence: 99%

Liquid chromatography‐tandem mass spectrometry method for simultaneous assessment of ofloxacin and dexamethasone in ocular biofluids: Application to ocular pharmacokinetic studies

Sanap

Bisen

Agrawal

et al. 2022

Separation Science Plus

View full text Add to dashboard Cite

A simple, fast, and responsive liquid chromatography-tandem mass spectrometry method was established and fully validated according to the United States Food and Drug Administration guidelines for the simultaneous quantitation of ofloxacin and dexamethasone in tear fluid and partially in aqueous humor and cornea. Samples were cleaned-up by single-step precipitation using methanol as an anti-solvent. Agilent SB C 18 column with 4.5 min total run time was used for chromatographic separation utilizing isocratic mode. Mass spectrometry detection was carried out by a triple quadrupole tandem mass spectrometer in the multiple reaction monitoring modes utilizing a positive electrospray ionization. The developed method showed a wide analytical range (ofloxacin: 0.7812-200 ng/ml and dexamethasone: 1.875-240 ng/ml) with good linearity (r 2 > 0.99) and acceptable accuracy and precision. It also showed excellent recoveries (>85% for analytes) and a negligible matrix effect. Finally, this method was successfully applied to determine the pharmacokinetic profile of clinically used eye drop solution of ofloxacin and dexamethasone in preclinical rabbit tear fluid, suggesting its suitability for therapeutic drug monitoring in clinical practices.

show abstract

“…Following this, there is a fascinating comparison of data, obtained by Monošík and Dragsted, using dried urine swab samples against wet urine samples for the quantitative determination by UHPLC-MS of a suitably chemically diverse range of dietary metabolites [2]. Subsequently there is a report of the successful LC-MS/MS method validation by Ferreira et al, using a water-based surrogate matrix, of dexamethasone in human aqueous humor [3]. Finally, we have the very intriguing and telling piece by Incamps et al [4] showing the possible effects of the plasma and serum matrix constituents on mass spectrometric-based measurement of protein analytes.…”

Section: Recent Thinking and Empirical Outcomesmentioning

confidence: 99%

Analytical Convergence in Surrogate Control Matrices

MacNeill

2018

Bioanalysis

View full text Add to dashboard Cite

Validation of Direct Method to Quantify Dexamethasone in Human Aqueous Humor by LC–MS/MS

Abstract: Our method is robust and sensitive enough to be applied in bioequivalence studies with human AH using only 20 μl of biological sample.

Cited by 8 publications

References 30 publications

Facile Synthesis and Size Control of 2D Cyclodextrin‐Based Metal–Organic Frameworks Nanosheet for Topical Drug Delivery

Facile Synthesis and Size Control of 2D Cyclodextrin‐Based Metal–Organic Frameworks Nanosheet for Topical Drug Delivery

Liquid chromatography‐tandem mass spectrometry method for simultaneous assessment of ofloxacin and dexamethasone in ocular biofluids: Application to ocular pharmacokinetic studies

Analytical Convergence in Surrogate Control Matrices

Contact Info

Product

Resources

About