A liquid chromatographic method using a reversed-phase hybrid stationary phase to control potential impurities of imipramine hydrochloride.
A reversed-phase liquid chromatographic method has been developed for the detection and control of impurities of imipramine hydrochloride at a level of 0.2 microg/ml (corresponding to 0.02 per cent in the procedure described). This method is included in a proposed revision of the monograph (Pharmeuropa 18.4) and replaces the thin-layer chromatographic method currently employed.
Dixon
S P
SP
Department of Pharmaceutical Sciences, University of Strathclyde, Glasgow, UK.
La Torre
F
F
Lodi
A
A
Miller
J H McB
JH
Skellern
G G
GG
D000929:Antidepressive Agents, Tricyclic / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D002855:Chromatography, Thin Layer; D004340:Drug Contamination / Q000517:prevention & control*; D005060:Europe; D007099:Imipramine / Q000032:analysis*; D004364:Pharmaceutical Preparations / Q000592:standards; D010602:Pharmacopoeias as Topic; D011786:Quality Control; D015203:Reproducibility of Results; D013678:Technology, Pharmaceutical / Q000379:methods*
D000929:Antidepressive Agents, Tricyclic; D004364:Pharmaceutical Preparations; D007099:Imipramine