LC determination and degradation study of droperidol.
A specific, high performance liquid chromatographic method for the determination of droperidol in the presence of its degradation products is described. The method is based on the use of an amide functionalized bonded phase column (LC-ABZ(+) Plus) and a simple mobile phase of methanol-sodium phosphate monobasic (0.05 M, pH 4.5) (40:60, v/v). It enables the resolution of eight compounds from the parent drug and from each other. The degradation was carried out in hydrochloric acid, sodium hydroxide and hydrogen peroxide. The main degradation products were identified. Application of the assay for a commercial preparation of droperidol for injection is presented.
Trabelsi
H
H
Laboratoire National de Contrôle des Médicaments 11bis, rue jebel Lakhdar, Bab Saadoun, 1006 Tunis, Tunisia. trhassen@rns.tn
Guettat
S
S
Bouzouita
K
K
Safta
F
F
D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D004329:Droperidol / Q000032:analysis*; D004355:Drug Stability; D006863:Hydrogen-Ion Concentration; D007202:Indicators and Reagents; D015203:Reproducibility of Results; D012996:Solutions; D013056:Spectrophotometry, Ultraviolet
D007202:Indicators and Reagents; D012996:Solutions; D004329:Droperidol