Denis Chris M, Baryla Nicole E
Lilly Analytical Research Laboratory, Eli Lilly Canada Inc., 3650 Danforth Avenue, Toronto, Ont., Canada M1N 2E8.
J Chromatogr A. 2006 Mar 31;1110(1-2):268-71. doi: 10.1016/j.chroma.2006.02.021. Epub 2006 Feb 28.
A fast, selective capillary electrophoresis (CE) method was developed for piperazine counter-ion analysis and applied to the analysis of an active pharmaceutical ingredient (API) that exists as a hemipiperazine salt. Due to the poor chromophore, the detection method chosen was indirect UV detection using benzylamine as the UV absorbing probe. Piperazine quantitation was performed using diethylamine as an internal standard and the method was validated for specificity, linearity, precision, and accuracy. The results indicate the method is suitable for piperazine counter-ion analysis in support of salt form characterization.
开发了一种快速、选择性毛细管电泳（CE）方法用于哌嗪抗衡离子分析，并将其应用于以半哌嗪盐形式存在的活性药物成分（API）的分析。由于发色团较差，选择的检测方法是使用苄胺作为紫外吸收探针的间接紫外检测。以二乙胺作为内标进行哌嗪定量，该方法在特异性、线性、精密度和准确度方面得到了验证。结果表明该方法适用于哌嗪抗衡离子分析以支持盐形式表征。
