Evaluation of HPLC with Pulsed-Amperometric Detection for Analysis of an Aminosugar Drug Substance

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Abstract
The present report describes development of a reversed-phase, ion-pairing, high-performance liquid chromatographic method with pulsed amperometric detection for analysis of a new aminosugar drug substance, N-butyldeoxynojirimycin, which has been identified as an anti-viral agent. the method has been used to determine the purity of chemical lots prior to formulation for use in clinical trials. Elements of the method development and validation described include selectivity optimization, linearity of response, and precision.