Tandem Labs, 1121 East 3900 South, Salt Lake City, UT 84124, USA.
J Pharm Biomed Anal. 2010 Dec 1;53(4):973-82. doi: 10.1016/j.jpba.2010.05.006. Epub 2010 May 12.
Traditional chiral chromatographic separation method development is time consuming even for an experienced chromatographer. This paper describes the application of computer software ACD Lab to facilitate the development of chiral separation for the quantitation of eszopiclone using LC-MS/MS technology. Assisted by ACD/Chrom Manager and LC Simulator software, the optimal chiral chromatographic development was completed within hours. The baseline chiral separation was achieved with a total cycle time of 3 min. For sample extraction method development, a Waters Oasis Sorbent Selection Plate containing four different sorbents was utilized. Optimal conditions were determined using a single plate under various load, wash and elution conditions. This was followed by a GLP validation which demonstrated excellent intra- and inter-day accuracy and precision for the quantitation of eszopiclone in human plasma at 1.00-100 ng/mL range using LC/MS/MS technology. This method was utilized to support multiple clinic bioequivalence studies.
传统的手性色谱分离方法的开发即使对于有经验的色谱学家来说也是耗时的。本文描述了使用计算机软件 ACD Lab 来促进手性分离的开发，用于使用 LC-MS/MS 技术定量测定艾司佐匹克隆。在 ACD/Chrom Manager 和 LC Simulator 软件的辅助下，在数小时内完成了最佳的手性色谱开发。总循环时间为 3 分钟即可实现基线手性分离。对于样品提取方法的开发，使用了包含四种不同吸附剂的 Waters Oasis 吸附剂选择板。在各种负载、洗涤和洗脱条件下，通过单板确定了最佳条件。随后进行了 GLP 验证，证明使用 LC/MS/MS 技术在 1.00-100ng/mL 范围内定量测定人血浆中的艾司佐匹克隆具有出色的日内和日间精密度和准确度。该方法用于支持多个临床生物等效性研究。
