Novel simultaneous method for the determination of avobenzone and oxybenzone in human plasma by UHPLC-MS/MS with phospholipid removal pretreatment: An application to a sunscreen clinical trial.
J Chromatogr B Analyt Technol Biomed Life Sci
; 1169: 122615, 2021 Apr 15.
Article
en En
| MEDLINE
| ID: mdl-33706185
ABSTRACT
Application of sunscreen is one of many ways to protect skin from the harmful effects of UV radiation. Sunscreen products are widely used and regulated as over-the-counter drug products in the United States. The U.S. Food and Drug Administration recommends an assessment of human systemic absorption of sunscreen active ingredients with a Maximal Usage Trial. The FDA conducted a clinical study to determine the systemic exposure of sunscreen active ingredients present in 4 commercially available sunscreen products of different formulation types under maximal usage conditions. To support this clinical study, a sensitive and specific LC-MS/MS method for the simultaneous determination of the two sunscreens avobenzone and oxybenzone in human plasma was developed. Phospholipid removal 96-well protein precipitation plates were used for sample clean-up and the extracted samples were chromatographed on an Ethylene-Bridged Hybrid (BEH) C18 column in isocratic flow using 10 mM ammonium formate in 0.1% formic acid and methanol (2476, v/v) as a mobile phase. A triple quadrupole mass spectrometer in multiple reaction monitoring (MRM) mode was used to acquire data. The method was validated as per current FDA bioanalytical method validation guidance, in the ranges 0.20-12.00 ng/mL for avobenzone and 0.40-300.00 ng/mL for oxybenzone. The validated method was used toanalyzethese active ingredients in human clinical study samples.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Propiofenonas
/
Protectores Solares
/
Benzofenonas
/
Cromatografía Líquida de Alta Presión
/
Espectrometría de Masas en Tándem
Tipo de estudio:
Clinical_trials
/
Diagnostic_studies
/
Guideline
/
Prognostic_studies
Límite:
Female
/
Humans
/
Male
Idioma:
En
Revista:
J Chromatogr B Analyt Technol Biomed Life Sci
Asunto de la revista:
ENGENHARIA BIOMEDICA
Año:
2021
Tipo del documento:
Article
País de afiliación:
Estados Unidos