A New Approach for Quantitative Determination of γ-Cyclodextrin in Aqueous Solutions: Application in Aggregate Determinations and Solubility in Hydrocortisone/γ-Cyclodextrin Inclusion Complex

J Pharm Sci. 2015 Nov;104(11):3925-3933. doi: 10.1002/jps.24608. Epub 2015 Aug 6.

Abstract

Fast and simple high-pressure liquid chromatographic (HPLC) method with charged aerosol detector (CAD) was developed for quantitation of γ-cyclodextrin (γCD) in aqueous solutions. The chromatographic system consisted of a C18 column (i.e., the stationary phase) and an aqueous mobile phase containing 7% (v/v) methanol. Calibration curve was obtained over the γCD concentration range of 0.005%-1% (w/v). The limit of detection and quantitation of γCD were 0.0001% and 0.0002% (w/v), respectively. Formation of γCD aggregates in aqueous solution and their critical aggregation concentration (cac) were determined by both conventional dynamic light scattering method and permeation method using HPLC-CAD for quantitative determination of γCD. The cac of γCD was determined to be 0.95% (w/v) and the amount of γCD self-aggregates increased with increasing γCD concentrations. Also, the developed HPLC-CAD method was used to determine the γCD phase-solubility profile in an aqueous hydrocortisone (HC)/γCD complexation medium. The maximum concentration of dissolved γCD and HC was determined to be 1.47% and 0.31% (w/v), respectively. The membrane permeation method was shown to be a reliable method for determination of metastable γCD aggregates. The HPLC-CAD method was successfully applied for quantitative determination of γCD in aqueous solutions during permeation and phase-solubility studies.

Keywords: HPLC (high-performance/pressure liquid chromatography); complex; cyclodextrin; nanoparticle; permeation; self assembly.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anti-Inflammatory Agents / administration & dosage
  • Anti-Inflammatory Agents / chemistry*
  • Chromatography, High Pressure Liquid
  • Dynamic Light Scattering
  • Hydrocortisone / administration & dosage
  • Hydrocortisone / chemistry*
  • Solubility
  • Water / chemistry
  • gamma-Cyclodextrins / chemistry*

Substances

  • Anti-Inflammatory Agents
  • gamma-Cyclodextrins
  • Water
  • gamma-cyclodextrin
  • Hydrocortisone