Rapid quantification of 2-hydroxypropyl-ß-cyclodextrin in liquid pharmaceutical formulations by (1)H nuclear magnetic resonance spectroscopy.
Eur J Pharm Sci
; 73: 20-8, 2015 Jun 20.
Article
en En
| MEDLINE
| ID: mdl-25797290
Quantification of 2-hydroxypropyl-ß-cyclodextrin (2-HP-ß-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-ß-CD as an active ingredient. A new technique is also mandatory for the development of future formulations in which 2-HP-ß-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-ß-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-ß-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.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Beta-Ciclodextrinas
/
Excipientes
Idioma:
En
Revista:
Eur J Pharm Sci
Asunto de la revista:
FARMACIA
/
FARMACOLOGIA
/
QUIMICA
Año:
2015
Tipo del documento:
Article
Pais de publicación:
Países Bajos