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Rapid Quantification of 2-hydroxypropyl-β-cyclodextrin in Liquid Pharmaceutical Formulations by (1)H Nuclear Magnetic Resonance Spectroscopy

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Rapid Quantification of 2-hydroxypropyl-β-cyclodextrin in Liquid Pharmaceutical Formulations by (1)H Nuclear Magnetic Resonance Spectroscopy

Gilles Dufour et al. Eur J Pharm Sci.

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.

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