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

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 (≤0.05 μg/ml), has run times of ≤15 min, and uses aliquot volumes adequate for pediatric studies (0....

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Bibliographic Details
Published in:Journal of pharmaceutical and biomedical analysis 1999-11, Vol.21 (3), p.657-667
Main Authors: Chu, Frances, Kiang, Chih-Hen, Sung, Man-Ling, Huang, Bee, Reeve, Russell L, Tarnowski, Thomas
Format: Article
Language:English
Subjects:
Analysis
Antiviral Agents - blood
Biological and medical sciences
Calibration
Chromatography, High Pressure Liquid - methods
Column switching
Drug Stability
Ganciclovir
Ganciclovir - blood
General pharmacology
Human plasma
Human serum
Humans
Medical sciences
Pharmacology. Drug treatments
Quality Control
Reference Standards
Reproducibility of Results
Reverse-phase liquid chromatography
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Summary: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 (≤0.05 μg/ml), has run times of ≤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 ( λ ex=278 nm; λ em=380 nm). The method has a validated range of 0.0400–4.00 μg/ml and an LLOQ of 0.0400 μg/ml. All intra- and inter-assay % C.V. values were
ISSN:0731-7085
1873-264X
DOI:10.1016/S0731-7085(99)00161-2