Optimization and validation of a new CE method for the determination of pantoprazole enantiomers

Abstract

A new CE method using sulfobutylether-beta-cyclodextrin (SBE-beta-CD) as chiral additive was developed and validated for the determination of pantoprazole enantiomers. The primary factors affecting its separation efficiency, which include chiral selector, buffer pH, organic additive, and applied voltage, were optimized. The best results were obtained using a buffer consisting of 50 mM borax-150 mM phosphate adjusted to pH 6.5, 20 mg/mL SBE-beta-CD, and a 10 kV applied voltage. The optimized method was validated for linearity, precision, accuracy, and proved to be robust. The LOD and LOQ for R-(+)-pantoprazole were 0.9 and 2.5 μg/mL, respectively. The method is capable of determining a minimum limit of 0.1% (w/w) of R-enantiomer in S-(-)-pantoprazole bulk samples.

Chiral Separation of the Enantiomers of Omeprazole and Pantoprazole by Capillary Electrophoresis

“…A validated method for combined analysis of the enantiomeric purity of both esomeprazole and related substances was based on use of Tris-phosphate buffer and 2-hydroxypropyl-β-CD as chiral selector [13]. Chiral separation of pantoprazole has been achieved by CE with a mixed borate-phosphate buffer at neutral pH and with sulfated-β-CD as chiral selector, but with the disadvantage of long migration time [14]. More recently, a copper(II)-l-histidine complex and HP-β-CD were successfully used as a dual chiral selector for separation of the enantiomers of four structurally related benzimidazole derivatives (lansoprazole, omeprazole, pantoprazole, and tenatoprazole) [15].…”

Recent advances in electrodriven enantioseparations

“…Therefore, the quality control of chiral drugs and their products involves also the determination of the unwanted stereoisomer (distomer) in the presence of the active stereoisomer (eutomer). During the reviewed period of time, several reports were published about the application of CE for the determination of enantiomeric purity and/or single active enantiomers in bulk drugs and/or final drug formulations including levocetirizine , ( R )‐modafinil , (–)‐huperzine A , ( R )‐pramipexol , ( R )‐(–)‐chloroquine , RS 86017 , L ‐methotrexate , ( S )‐pantoprazole , and escitalopram . The content of the lipoic acid enantiomers was determined in dietary supplements .…”

Chiral capillary electrophoresis with UV-excited fluorescence detection for the enantioselective analysis of 9-fluorenylmethoxycarbonyl-derivatized amino acids

“…Chiral analysis of AAs can be performed by gas chromatography [21] and high-performance liquid chromatography [22, 23], requiring costly chiral stationary phases and/or relatively large amounts of (chiral) derivatization agents [24–27]. In addition, upon repeated analysis of biological samples, lifetimes of chiral columns may be limited.…”