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Eur J Pharm Sci. 2015 Jun 20;73:20-8. doi: 10.1016/j.ejps.2015.03.005. Epub 2015 Mar 20.

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

Author information

1
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.
2
Laboratory of Pharmaceutical Technology and Biopharmacy, Department of Pharmacy, Centre Interfacultaire de Recherche du Médicament (CIRM), University of Liege, 4000 Liège, Belgium.
3
Laboratory of Medicinal Chemistry, Department of Pharmacy, Centre Interfacultaire de Recherche du Médicament (CIRM), University of Liege, 4000 Liège, Belgium.

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.

KEYWORDS:

(1)H NMR; Cyclodextrins; Pharmaceutical solutions; Quality assessment; Quantification

PMID:
25797290
DOI:
10.1016/j.ejps.2015.03.005
[Indexed for MEDLINE]
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