人血浆中氟康唑的高效液相色谱分析

Determination of Fluconazole in Plasma by Reversed-Phase High Performance Liquid Chromatography

目的建立血浆中氟康唑的高效液相色谱分析方法。方法以正常空白人血浆添加标准氟康唑及内标物对样品的前处理方法、仪器测试条件、定性定量分析方法进行考察和优化。对10名健康受试者单剂量口服氟康唑的药代谢动力学进行测定。结果血浆中氟康唑在0．25～10．0μg／ml范围内线性关系良好（r=0．9986）；定量检测的浓度下限是0．25μg/ml；检出限为0．1μg／／ml；分析方法的精密度日内RSD≤2．9％、日间RSD≤8．3％（n=5）；氟康唑在血液中的相对回收率在97．0±2．8％和108．4±2．4％之间；结论所建高效液相色谱分析方法准确、便捷，适应于法医学鉴定、临床血药浓度监测和药代动力学研究。

Objective For the purpose of more accurate and rapid analysis of fluconazole in plasma, a reversed-phase high performance liquid chromatography （HPLC） method was developed. Methods Standard fluconazole was added to the blank human plasma when the samples were pretreated. The pretreat- ment method of samples, the linear range, the precision, the recoveries in the plasma were investigated by using of human plasma spiked with standard fluconazole. Results The linear range was 0.25～10.0 μg/ml （ r = 0.9986） in plasma. The detective concentration limits were 0.25 μg/ml. The intra and inter-day precision of assay for fluconazole were less than 2.9% and 8.3% in plasma respectively. The recoveries of fluconazole were more than 97.0 ± 2.8% in plasma. The HPLC method has been used to investigate the blood concentration of fluconazole for health volunteers. Conclusion The HPLC method of quantitative analysis for fluconazole is simple, rapid and accurate. It is suitable for the blood concentration monitoring of fluconazole in the clinical and forensic medicine.