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Determination of (R,R)-glycopyrronium Bromide and Its Related Impurities by Ion-Pair HPLC

D Nebiu, M Walter, B Lachmann, H Kopelent, C R Noe

Pharmazie. 2007 Jun;62(6):406-10.

PMID: 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.

Chemicals Related in the Paper:

Catalog Number Product Name Structure CAS Number Price
AP13419619 Sodium 1-decanesulfonate Sodium 1-decanesulfonate 13419-61-9 Price
AP427496 Glycopyrrolate Related Compound C Glycopyrrolate Related Compound C 427-49-6 Price
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