TITLE

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

AUTHOR(S)
Blanco, Marcelo; González, Josep; Torras, Ester; Valverde, Ismael
PUB. DATE
January 2003
SOURCE
Analytical & Bioanalytical Chemistry;Jan2003, Vol. 375 Issue 1, p157
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
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%.
ACCESSION #
15124444

 

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