Assay and purity evaluation of 5-chlorooxindole by liquid chromatography

✍ Scribed by Stephen T. Colgan; Gary R. Haggan; Robert H. Reed

• Publisher: Elsevier Science
• Year: 1996
• Tongue: English
• Weight: 488 KB
• Volume: 14
• Category: Article
• ISSN: 0731-7085
• DOI: 10.1016/0731-7085(95)01712-7

✦ Synopsis

5-Chlorooxindole (5-CO) is a starting material for tenidap sodium, a pharmaceutical drug candidate produced by Pfizer. To insure potency and purity of the drug substance, it is necessary to demonstrate that commercial supplies of 5-CO are free from elevated levels of chemical analogs that could be carried through the synthetic scheme. This is accomplished using a single highly specific normal-phase chromatographic system that allows the quantitation of 5-CO concomitantly with all of its potential positional isomers. This paper describes the chromatographic system and its supportive validation data.