GlaxoSmithKline R&D, Park Road, Ware SG12 0DP, UK.
J Pharm Biomed Anal. 2011 Apr 5;54(5):900-10. doi: 10.1016/j.jpba.2010.11.007. Epub 2010 Nov 13.
This is the latest of a series of reviews focused on the analysis of genotoxic impurities. This review summarises the analytical approaches reported in the literature relating to hydrazine, hydrazines, hydrazides and hydrazones. It is intended to provide guidance for analysts needing to develop procedures to control such impurities, particularly where this is due to concerns relating to their potential genotoxicity. Of particular note is the wide variety of techniques employed, both chromatographic and spectroscopic, with most involving derivatisation. Such a wide variety of options allow the analyst a real choice in terms of selecting the most appropriate technique specific to their requirements. Several generic methodologies, covering the three main analytical approaches; i.e. HPLC (high performance liquid chromatography), GC (gas chromatography) and IC (ion chromatography), are also described.
这是一系列专注于遗传毒性杂质分析的综述中的最新一篇。本篇综述总结了文献中报道的与肼、联氨、酰肼和腙有关的分析方法。其目的是为需要开发控制这些杂质的程序的分析人员提供指导，特别是在这些杂质的潜在遗传毒性引起关注的情况下。特别值得注意的是，所使用的技术种类繁多，包括色谱法和光谱法，大多数都涉及衍生化。如此广泛的选择使得分析人员可以根据自己的要求选择最合适的技术。还描述了几种通用方法，涵盖了三种主要的分析方法：即高效液相色谱法（HPLC）、气相色谱法（GC）和离子色谱法（IC）。
