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

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.