胶带粘贴技术结合LC-MS法测定人体皮肤角质层中艾迪康唑浓度

Tape stripping technique in combination with LC-MS method for the determination of iodiconazole in human stratum corneum

采用胶带粘贴技术采集人体浅层皮肤样本，经提取处理后进行LC-MS测定，建立了人体皮肤角质层中艾迪康唑的定量分析方法。LC-MS测定以酮康唑为内标，甲醇-0.01%甲酸水溶液（65∶35）为流动相，经Shim-pack VP ODS C18 柱分离后，电喷雾离子化，选择性正离子检测。研究表明该方法在0.6~1 800 ng/mL范围内线性关系良好（r=0.999 8），方法回收率、批内及批间精密度均符合生物样本药物浓度测定要求。运用该方法对10例健康志愿者外用艾迪康唑乳膏后皮内药物浓度的动态变化过程进行了初步考察，结果表明该方法灵敏、专属，可用于人体局部外用艾迪康唑乳膏后角质层中药物浓度测定及人体皮肤药代动力学研究。

A quantitative analysis method of iodiconazole concentrations in human stratum corneum was established. Human superficial skin samples were obtained by tape stripping technique and iodiconazole concentrations were determined by LC-MS method after extraction. Ketoconazole was used as the internal standard（IS）. The analytes were chromatographically separated on a Shim-pack VP-ODS C18 column with the mobile phase consisting of methanol and 0. 01% formic acid aqueous solution（65 ∶35）. Mass spectrometer was operated in positive ion and selective ion monitoring（SIM）mode using electrospray ionization（ESI）technique. The method showed excellent linearity over the concentration range of 0. 6-1 800 ng/mL. The recovery and the intra- and inter-batch precisions met the requirements for the determination of biological samples. The dynamic process of intradermal drug concentrations in 10 healthy volunteers after topical application of iodiconazole cream was investigated using this method. The method proved to be selective and sensitive, and suitable for the determination of iodiconazole concentration in human stratum corneum and the pharmacokinetic study after topical application of iodiconazole cream.