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A rapid, sensitive HPLC method for the determination of ganciclovir in human plasma and serum.

Authors
  • Chu, F
  • Kiang, C H
  • Sung, M L
  • Huang, B
  • Reeve, R L
  • Tarnowski, T
Type
Published Article
Journal
Journal of Pharmaceutical and Biomedical Analysis
Publisher
Elsevier
Publication Date
Nov 01, 1999
Volume
21
Issue
3
Pages
657–667
Identifiers
PMID: 10701434
Source
Medline
License
Unknown

Abstract

A method for ganciclovir determination in human serum and plasma has been developed and validated. The method has a lower limit of quantification (LLOQ) adequate for sensitive pharmacokinetic studies ( < or = 0.05 microg/ml), has run times of < or = 15 min, and uses aliquot volumes adequate for pediatric studies (0.25 ml). In the method, proteinaceous material in serum or plasma is precipitated by trichloroacetic acid. An aliquot of the supernatant is analyzed by HPLC; automated column switching removes late-eluting materials that might interfere with the analyte peak in subsequent runs. Detection and quantification of ganciclovir is by fluorescence (lambda(ex) = 278 nm; lambda(em) = 380 nm). The method has a validated range of 0.0400-4.00 microg/ml and an LLOQ of 0.0400 microg/ml. All intra- and inter-assay % C.V. values were < 8%; all recoveries (accuracy) were within 7% of nominal values. No interference was observed by mycophenolic acid or its glucuronide metabolite, by AZT, salicylic acid, acetaminophen, ibuprofen, naproxen prednisone, acyclovir, or cyclosporine. Ganciclovir is very stable in the samples and the extract during storage and sample processing. Both serum and plasma methods have been validated for use and have been successfully used to analyze samples from clinical studies.

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