ApplicationIon chromatography of Amylamine (cas 110-58-7) and tert.-butylamine in pharmaceuticals

Add time:08/21/2019    Source:sciencedirect.com

Ion chromatographic (IC) methods have been developed for the assay of Amylamine (cas 110-58-7) in BMS-181 866-02 and tert.-butylamine (TBA) in BMS-188 494-04. BMS-181 866-02 is the penultimate intermediate in the synthesis of a novel thromboxane antagonist, BMS-180 291-02, which is undergoing clinical trials. Amylamine may be present as a trace impurity in BMS-181 866-02. BMS-188 494-04 is the TBA salt of the prodrug ester of BMS-187 745, a novel oral hypocholesterolemic agent. Chromatographic separations were accomplished under isocratic conditions using a Dionex CS-14 column with conductivity detection. The methods differ only in the composition of the methanesulfonic acid-acetonitrile mobile phase. The detection limit and minimum quantifiable levels for amylamine were 0.01% and 0.02%, respectively. The method was linear over the range studied (1–12.5 μg/ml, n = 7, r = 0.9993). The method for TBA was linear from 5 to 30% (w/w) (50–300 μg/ml, n = 8, r = 0.9993) of working sample concentration (1 mg/ml BMS-188 494-04). The precision and accuracy of the methods are presented.

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