Stability indicating LC method for the determination of pipamperone.
A high performance liquid chromatographic method for the determination of pipamperone in the presence of one related impurity and its degradation products is described. The method is based on the use of an amide functionalized bonded phase column (LC-ABZ+ Plus) and a mobile phase of acetonitrile-tetrahydrofuran-sodium phosphate monobasic (0.05 M, pH 6.5) (16:11:73, v/v/v). All peaks are eluted in <8 min. The method was demonstrated to be precise, accurate and specific. Degradation study showed that the drug is stable in acidic medium while it degrades under basic and oxidative conditions. The results indicated that the proposed method could be used in a stability assay.
Trabelsi
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Laboratoire National de Contrôle des Médicaments 11bis, Bab Saadoun, 1006 Tunis, Tunisia. trhassen@rns.tn
Hassen
I E
IE
Bouabdallah
S
S
Bouzouita
K
K
Safta
F
F
D014150:Antipsychotic Agents / Q000032:analysis*; D002090:Butyrophenones / Q000032:analysis*; D002138:Calibration; D002853:Chromatography, Liquid; D004355:Drug Stability; D006863:Hydrogen-Ion Concentration; D007202:Indicators and Reagents; D015203:Reproducibility of Results; D012972:Sodium Hydroxide / Q000737:chemistry; D012996:Solutions; D013056:Spectrophotometry, Ultraviolet
D014150:Antipsychotic Agents; D002090:Butyrophenones; D007202:Indicators and Reagents; D012996:Solutions; C005569:pipamperone; D012972:Sodium Hydroxide