Development and validation of a simple method for the extraction and quantification of crisaborole in skin layers

Biomed Chromatogr. 2019 Nov;33(11):e4664. doi: 10.1002/bmc.4664. Epub 2019 Aug 29.

Abstract

Crisaborole is a boron compound recently approved by the US Food and Drug Administration as a 2% ointment for the treatment of mild to moderate atopic dermatitis. This work describes a simple method for the quantification of the drug in the skin layers at the end of in-vitro permeation experiments. Chromatographic separation was carried out on a reverse-phase C18 column using a mixture of trifluoroacetic acid 0.05%-acetonitrile (55:45, v/v) as mobile phase, pumped at 1 ml/min. Column temperature was 35°C and UV detection was performed at 250 nm. The method was linear in the range of concentration from 0.06 to 6 μg/ml (R2 = 1) and was selective, precise and accurate. Depending on the solvent used, the LOQ ranged from 0.014 to 0.030 μg/ml and the LOD from 0.005 to 0.010 μg/ml. The extraction from all the skin layers was quantitative. The developed method was successfully tested in an in-vitro permeation study, proving to be an effective tool in the development of new formulations containing crisaborole.

Keywords: HPLC; atopic dermatitis; crisaborole; permeation study; skin layers.

MeSH terms

  • Animals
  • Boron Compounds / analysis*
  • Boron Compounds / chemistry
  • Boron Compounds / isolation & purification*
  • Bridged Bicyclo Compounds, Heterocyclic / analysis*
  • Bridged Bicyclo Compounds, Heterocyclic / chemistry
  • Bridged Bicyclo Compounds, Heterocyclic / isolation & purification*
  • Chromatography, High Pressure Liquid / methods
  • Chromatography, Reverse-Phase / methods
  • Dermatitis, Atopic
  • Limit of Detection
  • Linear Models
  • Reproducibility of Results
  • Skin / chemistry*
  • Spectrophotometry, Ultraviolet
  • Swine

Substances

  • Boron Compounds
  • Bridged Bicyclo Compounds, Heterocyclic
  • crisaborole