Determination of isotretinoin in human plasma by high performance liquid chromatography-electrospray ionization mass spectrometry

被引:9
作者
Wu, Lili [1 ,2 ]
Wu, Jingjing [3 ]
Zhou, Ke [4 ]
Cheng, Fang [1 ,2 ]
Chen, Yun [1 ,2 ]
机构
[1] Chinese Acad Med Sci, Dept Pharmacol, Inst Dermatol, Nanjing 210042, Peoples R China
[2] Peking Union Med Coll, Nanjing 210042, Peoples R China
[3] Guangdong Med Coll, Sino Amer Canc Res Inst, Dongguan 523808, Peoples R China
[4] Changzheng Hosp Tianjin, Dept Dermatol, Tianjin 300120, Peoples R China
关键词
Isotretinoin; HPLC-ESI-MS; Quantification; Bioequivalence study; TRANS-RETINOIC ACID; SOLID-PHASE EXTRACTION; 13-CIS-RETINOIC ACID; ALL-TRANS; 4-OXO METABOLITES; 4-OXO-13-CIS-RETINOIC ACID; HUMAN-BLOOD; ACNE; PHARMACOKINETICS; DISORDERS;
D O I
10.1016/j.jpba.2011.05.012
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
A rapid, sensitive and specific high performance liquid chromatography-electrospray ionization mass spectrometry (LC-ESI-MS) method for the quantification of 13-cis-retinoic acid (isotretinoin) in human plasma has been developed. Acitretin was employed as the internal standard (IS). The analytes were chromatographically separated on a Shimadzu Shim-pack VP-ODS C18 column (150 mm x 2.0 mm ID.) with a mobile phase consisting of acetonitrile and water (90:10, v/v). Detection was performed on a single quadrupole mass spectrometer using an electrospray ionization interface with the selected-ion monitoring (SIM) mode. The method showed excellent linearity (r = 0.9989) over the concentration range of 10-1500 ng/mL with good accuracy and precision. The intra- and inter-batch precisions were within 10% relative standard deviation. The recoveries were more than 80%. The validated method was successfully applied to a preliminary bioequivalence study of isotretinoin in 20 Chinese healthy male volunteers. (C) 2011 Elsevier B.V. All rights reserved.
引用
收藏
页码:324 / 329
页数:6
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