The Development of a High Performance Liquid Chromatographic Test for Impurities in 1-(2-Thienylethyl)-4-imidazoline-2-thione

A high performance liquid chromatographic (HPLC) procedure was devised for the determination of impurity levels in 1-(2-thienylethyl)-4-imidazoline-2-thione bulk compound. A gradient program with a mobile phase of 0.02 M sodium phosphate buffer in acetonitrile/water (apparent pH 6.9) was used with a...

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Bibliographic Details
Published in:Journal of liquid chromatography & related technologies 2003-03, Vol.26 (4), p.573-583
Main Author: B'Hymer, C.
Format: Article
Language:English
Subjects:
Analysis
Basic drug analysis
Biological and medical sciences
General pharmacology
Impurity test
Medical sciences
Pharmacology. Drug treatments
Zorbax Rx-C8 column
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Summary:A high performance liquid chromatographic (HPLC) procedure was devised for the determination of impurity levels in 1-(2-thienylethyl)-4-imidazoline-2-thione bulk compound. A gradient program with a mobile phase of 0.02 M sodium phosphate buffer in acetonitrile/water (apparent pH 6.9) was used with a Zorbax Rx-C8 column. The acetonitrile composition was increased linearly from 15 to 50% over a 40 min period and held at 50% for 20 min. Ultraviolet detection at 239 nm was used to quantify all components. The procedure was validated for accuracy using spiked levels (0.1-1.5% w/w) of two suspected known impurities. A three day, two column repeatability study showed consistent results with test batches of the compound.
ISSN:1082-6076
1520-572X
DOI:10.1081/JLC-120017904