Novel method for the determination of piperazine in pharmaceutical drug substances using hydrophilic interaction chromatography and evaporative light scattering detection

被引：34

作者：

McClintic, C

Remick, DM

Peterson, JA

Risley, DS ^{[1
]}

机构：

[1] Eli Lilly & Co, Lilly Corp Ctr, Lilly Res Labs, Biopharmaceut & Drug Delivery, Indianapolis, IN 46285 USA

[2] Univ Indianapolis, Dept Chem, Indianapolis, IN 46227 USA

来源：

JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES | 2003年 / 26卷 / 18期

关键词：

hydrophilic interaction chromatography; evaporative light scattering detector; piperazine; high performance liquid chromatography; counterion; salt form;

D O I：

10.1081/JLC-120025426

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

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.

引用

页码：3093 / 3104

页数：12

共 29 条

[1] HYDROPHILIC-INTERACTION CHROMATOGRAPHY FOR THE SEPARATION OF PEPTIDES, NUCLEIC-ACIDS AND OTHER POLAR COMPOUNDS [J].