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)-(+)-ke-toprofen. 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%. © Springer-Verlag 2002.
Original language | English |
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Pages (from-to) | 157-163 |
Journal | Analytical and Bioanalytical Chemistry |
Volume | 375 |
Issue number | 1 |
DOIs | |
Publication status | Published - 1 Jan 2003 |
Keywords
- Chiral CE
- Cyclodextrins
- Enantiomeric purity determination
- Ketoprofen
- Stability study