title: Determination of isotretinoin in human plasma by high performance liquid chromatography-electrospray ionization mass spectrometry.
abstract: 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 × 2.0 mm I.D.) 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.
authors.affiliation: Department of pharmacology, Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing 210042, China.
authors.forename: Lili
authors.initials: L
authors.lastname: Wu
authors.forename: Jingjing
authors.initials: J
authors.lastname: Wu
authors.forename: Ke
authors.initials: K
authors.lastname: Zhou
authors.forename: Fang
authors.initials: F
authors.lastname: Cheng
authors.forename: Yun
authors.initials: Y
authors.lastname: Chen
mesh_terms: D017255:Acitretin / Q000097:blood; D000284:Administration, Oral; D000328:Adult; D000704:Analysis of Variance; D002138:Calibration; D002214:Capsules; D002681:China; D002851:Chromatography, High Pressure Liquid / Q000592:standards; D018592:Cross-Over Studies; D006801:Humans; D015474:Isotretinoin / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics; D008297:Male; D008954:Models, Biological; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D021241:Spectrometry, Mass, Electrospray Ionization / Q000592:standards; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D002214:Capsules; D015474:Isotretinoin; D017255:Acitretin