title: Development and validation of a liquid chromatography-tandem mass spectrometry method for simultaneous determination of amlodipine, atorvastatin and its metabolites ortho-hydroxy atorvastatin and para-hydroxy atorvastatin in human plasma and its application in a bioequivalence study.
abstract: A sensitive, simple and rapid high-performance liquid chromatography coupled with positive ion electrospray ionization-tandem mass spectrometry (HPLC-ESI-MS/MS) method was developed for the simultaneous determination of amlodipine, atorvastatin and its metabolites ortho-hydroxy atorvastatin and para-hydroxy atorvastatin in human plasma. The analytes were extracted from human plasma through liquid-liquid extraction method. A mixture of methyl tert-butyl ether and ethyl acetate (50:50, v/v) was used as the extractant. The chromatographic separation was achieved on a CAPCELLPAK CR 1:4 (5 μm, 150 mm × 2.0 mm i.d.) column within 6.0 min with the mobile phase consisted of acetonitrile and ammonium acetate buffer (20mM) containing 0.3% formic acid (50:50, v/v). Data acquisition was carried out in multiple reaction monitoring (MRM) mode. The method was validated and was successfully applied to the bioequivalence study of combination tablets containing AM and AT with coadministered individual drugs in 50 healthy Chinese male volunteers.
authors.affiliation: Institute of Clinical Pharmacy, Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science & Technology, Wuhan 430022, PR China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Zhou
authors.forename: Jie
authors.initials: J
authors.lastname: Li
authors.forename: Xiaomeng
authors.initials: X
authors.lastname: He
authors.forename: Mengmeng
authors.initials: M
authors.lastname: Jia
authors.forename: Mingzhou
authors.initials: M
authors.lastname: Liu
authors.forename: Huqun
authors.initials: H
authors.lastname: Li
authors.forename: Zhengjiang
authors.initials: Z
authors.lastname: Xiong
authors.forename: Yue
authors.initials: Y
authors.lastname: Fan
authors.forename: Weiyong
authors.initials: W
authors.lastname: Li
mesh_terms: D017311:Amlodipine / Q000737:chemistry*; D000069059:Atorvastatin; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D006538:Heptanoic Acids / Q000737:chemistry*; D006801:Humans; D059625:Liquid-Liquid Extraction / Q000379:methods; D008297:Male; D011758:Pyrroles / Q000737:chemistry*; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*; D013607:Tablets / Q000737:chemistry; D053719:Tandem Mass Spectrometry / Q000379:methods*; D013810:Therapeutic Equivalency
chemical_list: D006538:Heptanoic Acids; D011758:Pyrroles; D013607:Tablets; D017311:Amlodipine; D000069059:Atorvastatin