| Autor: |
Murkitt GS; Drug Metabolism Division, Glaxo Group Research, Ware, Herts, UK., Trafankowska EZ, Dunne M, Manchee GR |
| Jazyk: |
angličtina |
| Zdroj: |
Journal of pharmaceutical and biomedical analysis [J Pharm Biomed Anal] 1994 Sep; Vol. 12 (9), pp. 1181-7. |
| DOI: |
10.1016/0731-7085(94)e0032-v |
| Abstrakt: |
GR117289X, 3-(3-Bromo-2-[2-(1H-tetrazol-5-yl)-phenyl]-bezofuran-5-yl methyl)-2-butyl- 5-chloro-3H-imidazole-4-carboxylic acid, 1, is an angiotensin II receptor antagonist. A sensitive, accurate and precise assay for the determination of 1 in human plasma and validation data is described. The assay consists of a novel solid-phase extraction using Certify II followed by a reversed-phase gradient HPLC separation with UV detection. The extraction procedure has been fully automated by a Zymate XP robot and linked on-line to the HPLC system. The analytical range for the assay is 5-250 ng ml-1 over which the assay is linear and specific for 1 with respect to endogenous plasma components and its tetrazole N2 glucuronide, the major circulating metabolite 2. For the fully automated procedure the intra-assay data indicate a maximum bias and coefficient of variation across the calibration range of +8.0 and 9.4%, respectively. The inter-assay data indicate a maximum bias and coefficient of variation across the calibration range of +8.0 and 11.1%, respectively. The extraction efficiency of the assay was approximately 75%. Both a manual and fully automated assay were applied to the analysis of 1 in plasma of volunteers from a number of clinical studies. The assay has been shown to be robust in sustained use over several months. |
| Databáze: |
MEDLINE |
| Externí odkaz: |
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