Rapid quantification of 2-hydroxypropyl-β-cyclodextrin in liquid pharmaceutical formulations by 1H nuclear magnetic resonance spectroscopy

Quantification of 2-hydroxypropyl-beta-cyclodextrin (2-HP-beta-CD) is not yet described in United States Pharmacopeia (USP) and European Pharmacopeia (EP). A useful quality control tool is therefore needed for the specific quantification in finished liquid pharmaceutical products, especially for formulations containing 2-HP-beta-CD as an active ingredient. A new technique is also mandatory for the development of future formulations in which 2-HP-beta-CD concentration could influence the properties of these formulations. Here, we described the use of H-1 NMR for the rapid quantification of 2-HP-beta-CD directly into pharmaceutical solutions without any extraction or separation steps. This technique was successfully applied to different pharmaceutical solutions comprising an i.v. solution (budesonide/2-HP-beta-CD complex), an eye drop solution (Indocollyre (R)) and an oral solution (Sporanox (R)). Specificity, linearity, precision (repeatability and intermediate precision), trueness, limits of quantification (LOQs) and accuracy were used as validation criteria. (C) 2015 Elsevier B.V. All rights reserved.