Quantitative determination of beta-cyclodextrin in a powder insulin formulation for nasal delivery using hydrophilic interaction chromatography with evaporative light scattering detection

Abstract

This study demonstrated the first application of hydrophilic interaction chromatography (HILIC) with evaporative light scattering detection (ELSD) for the analysis of beta-cyclodextrin in a peptide nasal formulation. The method utilized an Accucore™ 150 Amide HILIC packing together with an isocratic mobile phase of 65% acetonitrile/35% water with a runtime of 10 minutes and easily separated alpha-, beta- and gamma-cyclodextrins. The method was validated with respects to accuracy, precision, reproducibility, stability, specificity and sensitivity. This method provided better sensitivity compared to other reversed phase HPLC methods and was easier to run than other techniques for the quantitation of cyclodextrins in pharmaceutical formulations.

GRAPHICAL ABSTRACT

Keywords:

• Alpha-cyclodextrin
• beta-cyclodextrin
• evaporative light scattering detection
• gamma-cyclodextrin
• hydrophilic interaction chromatography
• nasal delivery