Determination of enantiomeric impurity of etodolac by capillary electrophoresis using (2-hydroxypropyl)-β-cyclodextrin

Abstract

A capillary electrophoresis method was developed to determine the impurity of etodolac enantiomers. (2-Hydroxypropyl)-beta-cyclodextrin (HP-beta-CD) was used as a chiral selector and ketoprofen as an internal standard to improve the peak area precision. The seperation of the etodolac enantiomers was achived within 35 min at 15 degrees C and its highest resolution was about 4.0 using phosphate buffer (0.1 M, pH 6.0) with 15 mM HP-beta-CD and UV detection at 225 nm with a reference wavelength at 360 nm. This method allowed determination of 0.2% of (R)-(-)-etodolac in (S)-(+)-etodolac and method validation showed adequate linearity over the required range.

Pharmaceuticals and Related Drugs

“…A second noted advantage is that it exhibits separation properties that are complementary to other materials. Representative examples of other chiral assays that have been designed for other specific compounds or groups of compounds are given in Table − .…”

Application of cyclodextrins in chiral capillary electrophoresis

“…CDs can separate enantiomers, as well as regioisomers. For example, chiral drugs can be separated together with their metabolites in one analysis , major and minor reaction products can be separated at the same time , and samples that contain less than 0.3% or even less than 0.1% of enantiomeric impurity can be reliably characterized.…”

“…Examples of commercially available randomly substituted CDs are neutral methylated CDs and 2‐hydroxypropylated CDs , and negatively charged carboxymethylated CDs and sulfated CDs . The only commercially available positively charged randomly substituted CD is quaternary ammonium β‐CD that has been used for the separation of negatively charged analytes .…”

Chiral selectors in CE: Recent developments and applications

“…2‐HP‐β‐CD seems to be the most widely applicable neutral CD derivative. It was used for the enantiomeric separation of amino acids, in combination with SDS and PEO , and chiral drugs, such as fluvastatin , β 2 ‐agonists , etodolac , the antimycotic drugs, ketoconazole and terconazole , and lodipine . This is due to its excellent solubilizer features and its excellent selectivity because of its polar and nonpolar substituent groups and the extra chiral centers that these groups provide.…”