Simple and Rapid HPLC-UV Method Using an Ultrafine Particle Octadecylsilane for Determination of Residual Fentanyl in Applied Durotep? MT Transdermal Matrix Patches and Its Clinical Application

摘要

A few complicated and time-consuming methods are available for the determination of residual fentanyl in Durotep? MT transdermal patches, however, their application to clinical settings is limited. The aim of this study was to develop a simple and rapid HPLC-UV method using an ultrafine particle octadecylsilane (ODS) for the determination of residual fentanyl in applied Durotep? MT transdermal matrix patches. Patch extraction involved sonicating a shredded Durotep? MT patch in acetonitrile for 15?min. Fentanyl separation was completed within 2?min using a 2.3-μm particle ODS column (50×4.6?mm i.d.) at a flow rate of 1.5?mL/min. No peaks interfering with fentanyl (1.27?min) and papaverine (0.89?min) as an internal standard were observed. The calibration curve for fentanyl was linear over the range of 0.015—9.0?mg as a Durotep? MT patch. The intra- and inter-assay precisions and accuracies of each patch were within 5.3% and 103.9—110.5% and within 8.2% and 97.1—104.3%, respectively. The validated method was applied to determine residual fentanyl in Durotep? MT patches used in 35 cancer patients. Although the plasma fentanyl concentration was significantly correlated with its measured absorption rate, the measured absorption rate normalized fentanyl concentration showed a large inter-individual variation. The validated simple and rapid HPLC-UV method established in the present study is helpful for evaluating the absorption rate of fentanyl in patients receiving Durotep? MT patches.