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
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概要
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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.
著者
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Yagi Tatsuya
Department Of Molecular And Cellular Pharmacology Tokyo University Of Pharmacy And Life Sciences
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NAITO Takafumi
Department of Clinical Pharmacy, Oita Medical University
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Kawakami Junichi
Department Of Hospital Pharmacy Hamamatsu University School Of Medicine
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Takashina Yoshiaki
Department of Hospital Pharmacy, Hamamatsu University School of Medicine
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Naito Takafumi
Department of Hospital Pharmacy, Hamamatsu University School of Medicine
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Yagi Tatsuya
Department of Hospital Pharmacy, Hamamatsu University School of Medicine
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