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用于从动物饲料中提取一种实验性HIV蛋白酶抑制剂药物的超临界流体萃取方法开发

Supercritical fluid extraction method development for extraction of an experimental HIV protease inhibitor drug from animal feed.

作者信息

Roston D A, Sun J J

机构信息

Searle Research and Development, Skokie, IL 60077, USA.

出版信息

J Pharm Biomed Anal. 1997 Jan;15(4):461-8. doi: 10.1016/s0731-7085(96)01876-6.

DOI:10.1016/s0731-7085(96)01876-6
PMID:8953489
Abstract

Supercritical fluid extraction (SFE) was evaluated as a sample preparation procedure for the recovery of experimental drugs from animal feed preparations that are generated during long-term toxicology studies. A commercially available supercritical fluid extractor was utilized to develop and validate an off-line procedure for the recovery of an experimental HIV protease inhibitor drug from animal feed. Extracts were analyzed with a conventional reversed-phase HPLC method. Elements of the SFE method developed that are described include optimization of the system temperature and selection of the extraction media modifier. The study emphasized the performance of two-day precision and accuracy studies. Precision and accuracy studies were carried out with SC-52151 levels of 0.05, 0.1 and 1.0% (w/w) and used an internal standard quantitation format. Also, the study utilized a relatively large analytical scale extraction vessel size of 10 ml to accomodate 6 g animal feed samples.

摘要

超临界流体萃取(SFE)被评估为一种样品制备方法,用于从长期毒理学研究中产生的动物饲料制剂中回收实验药物。使用市售的超临界流体萃取器开发并验证了一种离线方法,用于从动物饲料中回收一种实验性HIV蛋白酶抑制剂药物。提取物采用传统的反相高效液相色谱法进行分析。所开发的SFE方法的要素包括系统温度的优化和萃取介质改性剂的选择。该研究重点进行了为期两天的精密度和准确度研究。精密度和准确度研究在SC - 52151水平为0.05%、0.1%和1.0%(w/w)的条件下进行,并采用内标定量形式。此外,该研究使用了相对较大的10 ml分析规模萃取容器尺寸,以容纳6 g动物饲料样品。

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