Development of a liquid chromatographic method for the control of related substances in chlorprothixene hydrochloride.
The development of a reversed-phase liquid chromatographic method, using a mobile phase containing a mixture of anion and cation ion-pairing agents and a base-deactivated octyldecylsilyl column as stationary phase, is described for the control of all known impurities in (Z)-chlorprothixene hydrochloride (bulk drug). Validation of the method showed it to be reproducible, selective for both (Z) chlorprothixene hydrochloride and its E-isomer, accurate and linear over the concentration range of analysis with a limit of detection of 0.3 microgram ml-1.
Duignan
G M
GM
Department of Pharmaceutical Sciences, University of Strathclyde, Glasgow, UK.
Miller
J H
JH
Skellern
G G
GG
D014150:Antipsychotic Agents / Q000737:chemistry / Q000302:isolation & purification*; D002749:Chlorprothixene / Q000737:chemistry / Q000302:isolation & purification*; D002853:Chromatography, Liquid / Q000379:methods*; D008968:Molecular Conformation; D015203:Reproducibility of Results
D014150:Antipsychotic Agents; D002749:Chlorprothixene