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A rapid ion-pair HPLC method determines (R,R)-glycopyrronium bromide impurities, indicating its reliability for stability indicating assays.
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 °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 1ml · min–1. The analytical assay was validated according to international guidelines. The method is suitable for in-process control and as stability indicating assay.
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Nebiu et al. (2007) studied this question.
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