Determination of (R,R)-glycopyrronium bromide and its related impurities by ion-pair HPLC.
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.
Nebiu
D
D
Department of Medicinal Chemistry, Faculty of Life Sciences, University Vienna, Austria.
Walter
M
M
Lachmann
B
B
Kopelent
H
H
Noe
C R
CR
D000085:Acetates; D002021:Buffers; D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination; D006024:Glycopyrrolate / Q000032:analysis* / Q000138:chemical synthesis / Q000302:isolation & purification; D006863:Hydrogen-Ion Concentration; D018727:Muscarinic Antagonists / Q000032:analysis* / Q000138:chemical synthesis / Q000302:isolation & purification; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet; D013696:Temperature
D000085:Acetates; D002021:Buffers; D018727:Muscarinic Antagonists; C018824:ammonium acetate; D006024:Glycopyrrolate