title: Rapid quantification of 2-hydroxypropyl-β-cyclodextrin in liquid pharmaceutical formulations by (1)H nuclear magnetic resonance spectroscopy.
abstract: Quantification of 2-hydroxypropyl-β-cyclodextrin (2-HP-β-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-β-CD as an active ingredient. A new technique is also mandatory for the development of future formulations in which 2-HP-β-CD concentration could influence the properties of these formulations. Here, we described the use of (1)H NMR for the rapid quantification of 2-HP-β-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-β-CD complex), an eye drop solution (Indocollyre®) and an oral solution (Sporanox®). Specificity, linearity, precision (repeatability and intermediate precision), trueness, limits of quantification (LOQs) and accuracy were used as validation criteria.
authors: Laboratory of Pharmaceutical Technology and Biopharmacy, Department of Pharmacy, Centre Interfacultaire de Recherche du Médicament (CIRM), University of Liege, 4000 Liège, Belgium. Electronic address: gilles.dufour@ulg.ac.be.
authors: Gilles
authors: G
authors: Dufour
authors: Laboratory of Pharmaceutical Technology and Biopharmacy, Department of Pharmacy, Centre Interfacultaire de Recherche du Médicament (CIRM), University of Liege, 4000 Liège, Belgium.
authors: Brigitte
authors: B
authors: Evrard
authors: Laboratory of Medicinal Chemistry, Department of Pharmacy, Centre Interfacultaire de Recherche du Médicament (CIRM), University of Liege, 4000 Liège, Belgium.
authors: Pascal
authors: P
authors: de Tullio
mesh_terms: D000073738:2-Hydroxypropyl-beta-cyclodextrin; D019819:Budesonide / Q000008:administration & dosage; D002138:Calibration; D002626:Chemistry, Pharmaceutical; D005079:Excipients / Q000032:analysis*; D007213:Indomethacin / Q000008:administration & dosage; D017964:Itraconazole / Q000008:administration & dosage; D057230:Limit of Detection; D009682:Magnetic Resonance Spectroscopy; D015203:Reproducibility of Results; D047392:beta-Cyclodextrins / Q000032:analysis*
chemical_list: D005079:Excipients; D047392:beta-Cyclodextrins; D000073738:2-Hydroxypropyl-beta-cyclodextrin; D017964:Itraconazole; D019819:Budesonide; D007213:Indomethacin
keywords: (1)H NMR; Cyclodextrins; Pharmaceutical solutions; Quality assessment; Quantification