B. Kersten
Dec 1, 1992
Citations
0
Influential Citations
7
Citations
Journal
Chromatographia
Abstract
SummaryAn ion chromatographic method has been developed for the purity testing of 1-(butylamino)-1-deoxy-D-glucitol (BDG), a unique polyhydroxy aliphatic amine of pharmaceutical interest, in the presence of related amines and n-butylamine. Utilizing cation exchange chromatography, a comparative study of dilute molar solutions of hydrochloric acid (HCl) with millimolar amounts of DL-2,3-diaminopropionic acid (DAP) as eluent was performed to optimize the separation. An eluent of 10 mM HCl containing 0.01 mM DAP was found to be superior for the separation of the given analytes. The method was validated for the determination of BDG. The validation addressed linearity, accuracy, precision, and ruggedness of the method. The selectivity of the method was compared to an existing ion-pairing high-performance liquid chromatography method. In addition, the retention of these analytes was determined as a function of the reciprocal of the concentration of the exchangeable eluent cation. A plot of capacity factors of the organic cations vs the reciprocal of the eluent ion concentration showed good linearity. From the slope and y-intercept data, the major retention mechanism was interpreted as ion-exchange with solvophobic interactions.