Enantiomeric purity determination of ketoprofen by capillary electrophoresis: Development and validation of the method

Marcelo Blanco, Josep Maria González, Ester Torras, Ismael Valverde

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26 Citations (Scopus)

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 languageEnglish
Pages (from-to)157-163
JournalAnalytical and Bioanalytical Chemistry
Volume375
Issue number1
DOIs
Publication statusPublished - 1 Jan 2003

Keywords

  • Chiral CE
  • Cyclodextrins
  • Enantiomeric purity determination
  • Ketoprofen
  • Stability study

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