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Optimization and validation of a new CE method for the determination of pantoprazole enantiomers.
Electrophoresis. 2012 Jun; 33(11):1631-6.E

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.

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Publisher Full Text (DOI)

Authors+Show Affiliations

Guan J
School of Applied Chemistry, Shenyang University of Chemical Technology, Shenyang, China. Guanj0418@yahoo.com.cn
Yan F
No affiliation info available
Shi S
No affiliation info available
Wang S
No affiliation info available

MeSH

2-PyridinylmethylsulfinylbenzimidazolesDrug StabilityElectrophoresis, CapillaryHydrogen-Ion ConcentrationLimit of DetectionPantoprazoleReproducibility of ResultsStereoisomerismbeta-Cyclodextrins

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22736366

Citation

Guan, Jin, et al. "Optimization and Validation of a New CE Method for the Determination of Pantoprazole Enantiomers." Electrophoresis, vol. 33, no. 11, 2012, pp. 1631-6.
Guan J, Yan F, Shi S, et al. Optimization and validation of a new CE method for the determination of pantoprazole enantiomers. Electrophoresis. 2012;33(11):1631-6.
Guan, J., Yan, F., Shi, S., & Wang, S. (2012). Optimization and validation of a new CE method for the determination of pantoprazole enantiomers. Electrophoresis, 33(11), 1631-6. https://doi.org/10.1002/elps.201100650
Guan J, et al. Optimization and Validation of a New CE Method for the Determination of Pantoprazole Enantiomers. Electrophoresis. 2012;33(11):1631-6. PubMed PMID: 22736366.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Optimization and validation of a new CE method for the determination of pantoprazole enantiomers. AU - Guan,Jin, AU - Yan,Feng, AU - Shi,Shuang, AU - Wang,Silin, PY - 2012/6/28/entrez PY - 2012/6/28/pubmed PY - 2012/10/16/medline SP - 1631 EP - 6 JF - Electrophoresis JO - Electrophoresis VL - 33 IS - 11 N2 - 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. SN - 1522-2683 UR - https://www.unboundmedicine.com/medline/citation/22736366/Optimization_and_validation_of_a_new_CE_method_for_the_determination_of_pantoprazole_enantiomers_ DB - PRIME DP - Unbound Medicine ER -