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J Chromatogr. 1991 Jul 17;568(1):246-52.

Quantitation of the new hypoglycaemic agent AG-EE 388 ZW in human plasma by automated high-performance liquid chromatography with electrochemical detection.

Author information

1
Department of Pharmacokinetics and Metabolism, Dr. Karl Thomae GmbH, Biberach, Germany.

Abstract

A sensitive and selective high-performance liquid chromatographic assay has been developed for a new hypoglycaemic agent AG-EE 388 ZW (I) in human plasma. Plasma samples containing I were acidified with 0.2 M hydrochloric acid, directly injected into C2 reversed-phase pre-columns, and cleaned up on-line. After pre-column switching, the substance was separated isocratically in 15 min on a C18 reversed-phase column. Quantitation was performed after amperometric detection by external standard calibration curves. The linearity of the assay was demonstrated over the therapeutic concentration range 5-200 ng/ml. between-day coefficient of variation was 9.2% at 30 ng/ml. The limit of detection was 5 ng/ml in plasma. Determination of human plasma samples after intravenous and oral administration of 1 mg of 14C-labelled I demonstrated the applicability of the assay for pharmacokinetic studies in humans.

PMID:
1770103
DOI:
10.1016/0378-4347(91)80360-o
[Indexed for MEDLINE]

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