Development and Validation of a High-Performance Liquid Chromatography Assay for Voriconazole

Author:

Pennick Gennethel J.1,Clark Martin2,Sutton Deanna A.1,Rinaldi Michael G.13

Affiliation:

1. Department of Pathology, University of Texas Health Science Center at San Antonio

2. Pfizer Limited, Sandwich, United Kingdom

3. Audie Murphy Division, South Texas Veterans Health Care System, San Antonio, Texas

Abstract

ABSTRACT An analytical method for the determination of voriconazole (UK-109,496; Pfizer) in plasma was developed and validated. The method utilizes solid-phase extraction technology and high-performance liquid chromatography. The lower limit of quantitation is 0.2 μg/ml, and the range of linearity tested was 0.2 to 10 μg/ml.

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

Reference6 articles.

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2. NCCLS. 2001. Evaluation of the linearity of quantitative analytical method; proposed guidelines—second edition. EP6-P2 vol. 21 no. 20. NCCLS Wayne Pa.

3. NCCLS. 1999. Statistical quality control for quantitative measurements: principles and definition: approved guidelines document C24-A2 vol. 19 no. 5 second ed. NCCLS Wayne Pa.

4. Comparison of High-Performance Liquid Chromatographic and Microbiological Methods for Determination of Voriconazole Levels in Plasma

5. Shah, V., K. Midha, S. Dighe, I. McGilveray, J. Skelly, A. Yacobi, T. Layloff, C. Viswanathan, C. Cook, R. McDowall, K. Pittman, and S. Spector. 1992. Analytical methods validation: bioavailability, bioequivalence, and pharmacokinetic studies. J. Pharm. Sci.81:309-312.

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