Abstract.
A simple, fast capillary electrophoresis method for determining the total ketoprofen content in an oral pharmaceutical formulation is proposed. The addition of 75 mM of heptakis(tri-O-methyl)-β-cyclodextrin to the background electrolyte allows the quantitation of the enantiomeric impurity of (R)-(–)-ketoprofen contained in the formulation. A relative limit of detection is proposed as a measure of the lowest detectable enantiomeric impurity and the results show that the method can detect the minor enantiomer at levels as low as 0.04% in (S)-(+)-ketoprofen. The chiral method was validated following ICH recommendations and the quality parameters obtained show the suitability of the proposed method. The analysis of samples examined during the course of a stability study under chiral and achiral conditions revealed that the total ketoprofen content did not change significantly with time and the enantiomeric impurity range was 0.1–0.4%.
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Blanco, M., González, J., Torras, E. et al. Enantiomeric purity determination of ketoprofen by capillary electrophoresis: development and validation of the method . Anal Bioanal Chem 375, 157–163 (2003). https://doi.org/10.1007/s00216-002-1629-8
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DOI: https://doi.org/10.1007/s00216-002-1629-8