HPLC assay for albendazole and metabolites in human plasma for clinical pharmacokinetic studies

Dennis Kitzman, Kuei Ju Cheng, Lawrence Fleckenstein

Research output: Contribution to journalArticle

49 Citations (Scopus)

Abstract

A sensitive and selective HPLC chromatography method using UV detection (295 nm) was developed for the determination of albendazole, albendazole sulfoxide (ABZSO), and albendazole sulfone (ABZSO2) in human plasma. Albendazole, ABZSO, ABZSO2, and the internal standard, oxibendazole, were extracted from human plasma by loading onto a conditioned C18 SPE cartridge, rinsing with 15% methanol, and eluting with 90% methanol. Samples were evaporated under a stream of nitrogen, reconstituted with mobile phase, 1.25% triethylamine in water-methanol-acetonitrile (72:15:13, v/v/v) (pH* 3.1), and injected onto a Waters μBondapak™ Phenyl 3.9×300 mm HPLC column. Mobile phase flow rate was 1.0 ml/min. The retention times of albendazole, ABZSO, ABZSO2, and the internal standard were approximately 24.4, 7.9, 13.4, and 11.3 min, respectively. Total run time was 30 min. The assay was linear for concentration ranges in human plasma of 20-600 ng/ml for albendazole, 20-1000 ng/ml for ABZSO, and 20-300 ng/ml for ABZSO2. The analysis of quality control samples demonstrated excellent precision. Coefficients of variation for albendazole (20, 400, 600 ng/ml) were 6.7, 8.1 and 7.0%; ABZSO (20, 400, 800 ng/ml) were 6.0, 8.5 and 5.9%; ABZSO2 (20, 150, 300 ng/ml) were 3.1, 3.9 and 2.3%, respectively. The method appears to be robust and has been applied to a pharmacokinetic study of albendazole in healthy volunteers.

Original languageEnglish
Pages (from-to)801-813
Number of pages13
JournalJournal of Pharmaceutical and Biomedical Analysis
Volume30
Issue number3
DOIs
Publication statusPublished - Sep 30 2002
Externally publishedYes

Fingerprint

Plasma (human)
Albendazole
Pharmacokinetics
Metabolites
Assays
High Pressure Liquid Chromatography
Methanol
Water
Chromatography
Quality Control
Quality control
Clinical Studies
Healthy Volunteers
Nitrogen
Flow rate
albendazole sulfoxide

Keywords

  • Albendazole
  • Albendazole sulfone
  • Albendazole sulfoxide
  • HPLC

ASJC Scopus subject areas

  • Analytical Chemistry
  • Pharmaceutical Science

Cite this

HPLC assay for albendazole and metabolites in human plasma for clinical pharmacokinetic studies. / Kitzman, Dennis; Cheng, Kuei Ju; Fleckenstein, Lawrence.

In: Journal of Pharmaceutical and Biomedical Analysis, Vol. 30, No. 3, 30.09.2002, p. 801-813.

Research output: Contribution to journalArticle

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abstract = "A sensitive and selective HPLC chromatography method using UV detection (295 nm) was developed for the determination of albendazole, albendazole sulfoxide (ABZSO), and albendazole sulfone (ABZSO2) in human plasma. Albendazole, ABZSO, ABZSO2, and the internal standard, oxibendazole, were extracted from human plasma by loading onto a conditioned C18 SPE cartridge, rinsing with 15{\%} methanol, and eluting with 90{\%} methanol. Samples were evaporated under a stream of nitrogen, reconstituted with mobile phase, 1.25{\%} triethylamine in water-methanol-acetonitrile (72:15:13, v/v/v) (pH* 3.1), and injected onto a Waters μBondapak™ Phenyl 3.9×300 mm HPLC column. Mobile phase flow rate was 1.0 ml/min. The retention times of albendazole, ABZSO, ABZSO2, and the internal standard were approximately 24.4, 7.9, 13.4, and 11.3 min, respectively. Total run time was 30 min. The assay was linear for concentration ranges in human plasma of 20-600 ng/ml for albendazole, 20-1000 ng/ml for ABZSO, and 20-300 ng/ml for ABZSO2. The analysis of quality control samples demonstrated excellent precision. Coefficients of variation for albendazole (20, 400, 600 ng/ml) were 6.7, 8.1 and 7.0{\%}; ABZSO (20, 400, 800 ng/ml) were 6.0, 8.5 and 5.9{\%}; ABZSO2 (20, 150, 300 ng/ml) were 3.1, 3.9 and 2.3{\%}, respectively. The method appears to be robust and has been applied to a pharmacokinetic study of albendazole in healthy volunteers.",
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N2 - A sensitive and selective HPLC chromatography method using UV detection (295 nm) was developed for the determination of albendazole, albendazole sulfoxide (ABZSO), and albendazole sulfone (ABZSO2) in human plasma. Albendazole, ABZSO, ABZSO2, and the internal standard, oxibendazole, were extracted from human plasma by loading onto a conditioned C18 SPE cartridge, rinsing with 15% methanol, and eluting with 90% methanol. Samples were evaporated under a stream of nitrogen, reconstituted with mobile phase, 1.25% triethylamine in water-methanol-acetonitrile (72:15:13, v/v/v) (pH* 3.1), and injected onto a Waters μBondapak™ Phenyl 3.9×300 mm HPLC column. Mobile phase flow rate was 1.0 ml/min. The retention times of albendazole, ABZSO, ABZSO2, and the internal standard were approximately 24.4, 7.9, 13.4, and 11.3 min, respectively. Total run time was 30 min. The assay was linear for concentration ranges in human plasma of 20-600 ng/ml for albendazole, 20-1000 ng/ml for ABZSO, and 20-300 ng/ml for ABZSO2. The analysis of quality control samples demonstrated excellent precision. Coefficients of variation for albendazole (20, 400, 600 ng/ml) were 6.7, 8.1 and 7.0%; ABZSO (20, 400, 800 ng/ml) were 6.0, 8.5 and 5.9%; ABZSO2 (20, 150, 300 ng/ml) were 3.1, 3.9 and 2.3%, respectively. The method appears to be robust and has been applied to a pharmacokinetic study of albendazole in healthy volunteers.

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