Determination of (R,R)-glycopyrronium bromide and its related impurities by ion-pair HPLC.
Pharmazie
; 62(6): 406-10, 2007 Jun.
Article
em En
| MEDLINE
| ID: mdl-17663184
ABSTRACT
A simple, rapid and specific ion-pair HPLC method for the determination of (R,R)-glycopyrronium bromide and its related impurities is presented, and parameters affecting the chromatographic properties of these compounds are discussed. Optimal analyte separation was achieved on base deactivated Nucleosil at 40 degrees C, using phosphate buffer pH 2.30 with sodium-1-decanesulfonate (0.01 M)/methanol (35/65; v/v) as eluent for isocratic elution at a flow rate 1 ml x min(-1). The analytical assay was validated according to international guidelines. The methodis suitable for in-process control and as stability indicating assay.
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Base de dados:
MEDLINE
Assunto principal:
Antagonistas Muscarínicos
/
Glicopirrolato
Idioma:
En
Ano de publicação:
2007
Tipo de documento:
Article