Determination of homotaurine as impurity in calcium acamprosate by capillary zone electrophoresis.
A method is reported which allows the quantification of homotaurine as an impurity in the drug. After addition of taurine as an internal standard, the sample is derivatised with fluorescamine at ambient temperature in 10 mM borate buffer, pH 9.2. The analytes are separated by capillary zone electrophoresis in a 31.2 cm (21 cm to the detector) x 100 microns I.D. fused-silica capillary at a potential of +7 kV and 25 degrees C. A 40 mM borate buffer, pH 9.2, is used as the electrolyte and detection is carried out at 205 nm. The validation tests showed that the method is reliable between 0.01% and 0.15% (m/m) of homotaurine with respect to the active drug. The limits of quantitation (0.01%, m/m) and detection (0.004%, m/m) allows to control the homotaurine content of the drug substance for which the maximum tolerated level is 0.05% (m/m). The proposed procedure (derivatisation and separation) developed in CE is rapid (20-25 min) by comparison to that currently used in HPLC (75 min). Satisfactory agreement was found between several batches of acamprosate analysed by CE and HPLC.
Fabre
H
H
Laboratoire de Chimie Analytique, Faculté de Pharmacie, Montpellier, France.
Perrin
C
C
Bosc
N
N
D000077443:Acamprosate; D002138:Calibration; D004573:Electrolytes; D019075:Electrophoresis, Capillary / Q000379:methods*; D005450:Fluorescamine / Q000737:chemistry; D007267:Injections; D016014:Linear Models; D011786:Quality Control; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet; D013654:Taurine / Q000031:analogs & derivatives* / Q000032:analysis / Q000737:chemistry
D004573:Electrolytes; D013654:Taurine; D005450:Fluorescamine; C001355:tramiprosate; D000077443:Acamprosate