Novel Method for the Determination of Piperazine in Pharmaceutical Drug Substances Using Hydrophilic Interaction Chromatography and Evaporative Light Scattering Detection

摘要

A novel method for the determination of piperazine in pharmaceutical drug substances was developed using high performance liquid chromatography (HPLC) with evaporative light scattering detection (ELSD). This method uses the hydrophilic interaction chromatography (HILIC) mode on a cyanopropyl (CN) bonded stationary phase. Optimization of organic modifier and acid composition in the mobile phase resulted in robust chromatography conditions with excellent resolution, peak shape and retention time for the piperazine peak. The method was further evaluated with respect to linearity, precision, selectivity, limit of detection (LOD), and reproducibility. Based on the data provided, this HPLC-ELSD method demonstrated acceptable levels of linearity, precision, LOD, and selectivity for determination of piperazine.