title: Quantification of voriconazole in human plasma by high-performance liquid chromatography-electrospray ionization mass spectrometry: application to a bioequivalence study.
abstract: A sensitive and specific liquid chromatography-electrospray ionization mass spectrometry (LC-ESI-MS) method was developed and validated for the identification and quantification of voriconazole (VRC, CAS 137234-62-9) in human plasma. Following liquid-liquid extraction, VRC and loratadine (internal standard, CAS 79794-75-5) were separated using a mobile phase comprised of methanol: water (0.1% formic acid) = 75:25 v/v on a Shimadzu Shim-pack VP-ODS C18 (150 x 2.0 mm ID, 5 microm) column and analyzed by electrospray ionization mass spectrometry. The chromatographic separation was achieved in less than 6 min. The standard curves were linear (r = 0.9994) over the concentration range of 2-2000 ng/mL for VRC and had good accuracy and precision. Both intra- and inter-batch standard deviations were less than 15%. The method was successfully applied to study the comparative bioavailability of VRC tablets test vs. reference in healthy Chinese volunteers through the statistical comparison of pharmacokinetic parameters obtained with the two formulations.
authors.affiliation: Key Laboratory of Drug Quality Control and Pharmacovigilance (China Pharmaceutical University), Ministry of Education, Nanjing, PR China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Cheng
authors.forename: Zun-Jian
authors.initials: ZJ
authors.lastname: Zhang
authors.forename: Yuan
authors.initials: Y
authors.lastname: Tian
authors.forename: Wen-Jing
authors.initials: WJ
authors.lastname: Li
authors.forename: Wei
authors.initials: W
authors.lastname: Wei
mesh_terms: D000328:Adult; D000935:Antifungal Agents / Q000097:blood*; D019540:Area Under Curve; D002138:Calibration; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D006207:Half-Life; D006801:Humans; D008297:Male; D011743:Pyrimidines / Q000097:blood*; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D012996:Solutions; D012997:Solvents; D021241:Spectrometry, Mass, Electrospray Ionization; D013810:Therapeutic Equivalency; D014230:Triazoles / Q000097:blood*; D065819:Voriconazole
chemical_list: D000935:Antifungal Agents; D011743:Pyrimidines; D012996:Solutions; D012997:Solvents; D014230:Triazoles; D065819:Voriconazole