Quantification of voriconazole in human plasma by high-performance liquid chromatography–electrospray ionization mass spectrometry: application to a bioequivalence study

Ying Cheng; Zun-Jian Zhang; Yuan Tian; Wen-Jing Li; Wei Wei

doi:10.1055/s-0031-1296179

Arzneimittelforschung, Inhaltsverzeichnis

Arzneimittelforschung 2011; 61(2): 132-139
DOI: 10.1055/s-0031-1296179

Antibiotics · Antimycotics · Antiparasitics · Antiviral Drugs · Chemotherapeutics · Cytostatics

Editio Cantor Verlag Aulendorf (Germany)

Quantification of voriconazole in human plasma by high-performance liquid chromatography–electrospray ionization mass spectrometry: application to a bioequivalence study

Ying Cheng

¹Key Laboratory of Drug Quality Control and Pharmacovigilance (China Pharmaceutical University), Ministry of Education, Nanjing, P. R. China

²Center for Instrumental Analysis, China Pharmaceutical University, Nanjing, P. R. China

,

Zun-Jian Zhang

¹Key Laboratory of Drug Quality Control and Pharmacovigilance (China Pharmaceutical University), Ministry of Education, Nanjing, P. R. China

²Center for Instrumental Analysis, China Pharmaceutical University, Nanjing, P. R. China

,

Yuan Tian

¹Key Laboratory of Drug Quality Control and Pharmacovigilance (China Pharmaceutical University), Ministry of Education, Nanjing, P. R. China

²Center for Instrumental Analysis, China Pharmaceutical University, Nanjing, P. R. China

,

Wen-Jing Li

¹Key Laboratory of Drug Quality Control and Pharmacovigilance (China Pharmaceutical University), Ministry of Education, Nanjing, P. R. China

²Center for Instrumental Analysis, China Pharmaceutical University, Nanjing, P. R. China

,

Wei Wei

³Institute of Clinical Pharmacology, Anhui Medical University, Hefei, P. R. China

› Institutsangaben

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 × 2.0 mm ID, 5 μrn) 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.

Key words

Antifungal - Bioequivalence - CAS 137234-62-9 - HPLC-ESI-MS - Human plasma - Voriconazole

Volltext

Referenzen

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