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  • Title: Determination of isotretinoin in human plasma by high performance liquid chromatography-electrospray ionization mass spectrometry.
    Author: Wu L, Wu J, Zhou K, Cheng F, Chen Y.
    Journal: J Pharm Biomed Anal; 2011 Sep 10; 56(2):324-9. PubMed ID: 21664787.
    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.
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