摘要

A sensitive and accurate liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the determination of tacrolimus in skin and receptor medium was established and validated. Chromatographic separation was achieved on an Agilent Zorbax SB-C18 column. The mobile phase was 0.05% formic acid in water-acetonitrile (30:65, v/v) and delivered at a flow rate of 0.3 mL/min. The LC-MS/MS method was quantitatively evaluated in terms of selectivity, linearity, precision, accuracy, recovery and stability, confirming its suitability for the determination. Then the method was applied to a permeation study which was carried on vertical diffusion cells across excised pig skin. The trail and reference formulation had shown similar transdermal parameters including drug retention in skin, steady transdermal flux and accumulative permeation amount by 24 h. These results showed that the established method was precise, accurate and can be applied to permeation study of tacrolimus dermal formulations.