Saunders Kenneth C, Ghanem Ashraf, Boon Hon Wei, Hilder Emily F, Haddad Paul R
Pfizer Global Research and Development, Sandwich, UK.
Anal Chim Acta. 2009 Oct 12;652(1-2):22-31. doi: 10.1016/j.aca.2009.05.043. Epub 2009 Jun 7.
In order to support drug discovery and development studies within the pharmaceutical industry there has been an increased use of innovative bioanalytical assays and associated analytical technology. Performing quantitative bioanalysis in a variety of biological matrices can also involve the use of sample preparation techniques, complex HLPC column switching and microfluidic systems. Development of assays for diverse therapeutic agents in biomatrices, such as plasma and urine, can be very technically challenging to obtain the sensitivity, speed and specificity required. This challenge focuses on the quantification of drugs and metabolites at very low concentration levels, in an excess of biological matrix and in a high-throughput manner. One area of wide interest is the use and application of monolithic phases where emerging technology has been implemented successfully. This review presents an overview of the application of monolithic phases in a bioanalytical setting, including the bioanalytical challenges that need to be overcome; the synthesis, use and applicability of monolithic phases (with emphasis on polymer-based phases); the currently available bioanalytical techniques and approaches; and future possibilities for these phases.
为了支持制药行业内的药物发现和开发研究，创新的生物分析方法及相关分析技术的使用日益增加。在各种生物基质中进行定量生物分析还可能涉及样品制备技术、复杂的高效液相色谱柱切换和微流控系统的使用。开发用于生物基质（如血浆和尿液）中多种治疗药物的分析方法，要获得所需的灵敏度、速度和特异性，在技术上可能极具挑战性。这一挑战集中在以高通量方式在大量生物基质中对极低浓度水平的药物和代谢物进行定量。一个备受广泛关注的领域是整体固定相的使用和应用，新兴技术已在该领域成功实施。本综述概述了整体固定相在生物分析环境中的应用，包括需要克服的生物分析挑战；整体固定相的合成、使用和适用性（重点是基于聚合物的固定相）；当前可用的生物分析技术和方法；以及这些固定相的未来可能性。
