title: Determination of rabeprazole enantiomers in commercial tablets using immobilized cellulose-based stationary phase.
abstract: Rabeprazole is one of the latest proton-pump inhibitors used for treatment of several gastrointestinal disorders. For therapeutic applications, rabeprazole has been administered as a mixture of R-(+) and S-(-) enantiomers. Owing to pharmacological and toxicological differences between stereoisomers, chiral recognition has now become an integral part of drug research and development. A simple and rapid liquid chromatographic method for enantioselective separation and determination of R-(+) and S-(-) enantiomers of rabeprazole in bulk drug and pharmaceutical formulations was developed. Chiralpak IC (150 × 4.6 mm, 5 μm) column and μmobile phase containing hexane:ethanol:ethylenediamine (30:70:0.05 v/v) in an isocratic mode yielded baseline separation with resolution greater than 6.0 at 35 °C. Effects of additives and n-hexane were evaluated. Optimized condition was validated as per ICH guidelines. The method has good linearity, high sensitivity with LOD was 0.01 μg/mL and LOQ was 0.03 μg/mL for both enantiomers. Intra-day precision varied between 0.44 and 1.79% for S-(-) enantiomer, 0.65 and 1.97% for R-(+) enantiomer. Relative standard deviations of inter-day precision were less than 1.81% for both enantiomers. The percentage recovery for both enantiomers of rabeprazole ranged between 99.81 and 101.95%, 98.82 and 101.36% in material and tablets, respectively. The method was successfully applied to determine content of each enantiomer in commercial tablets.
authors.affiliation: College of Pharmacy, Kangwon National University, Chuncheon, 24341, Korea.
authors.forename: Miri
authors.initials: M
authors.lastname: Kim
authors.affiliation: College of Pharmacy, Kangwon National University, Chuncheon, 24341, Korea.
authors.forename: Su Kyung
authors.initials: SK
authors.lastname: Yu
authors.affiliation: College of Pharmacy, Kangwon National University, Chuncheon, 24341, Korea.
authors.forename: Quoc-Ky
authors.initials: QK
authors.lastname: Truong
authors.affiliation: College of Pharmacy, Kangwon National University, Chuncheon, 24341, Korea.
authors.forename: Xuan-Lan
authors.initials: XL
authors.lastname: Mai
authors.affiliation: College of Pharmacy, Kangwon National University, Chuncheon, 24341, Korea.
authors.forename: Hyun Kyu
authors.initials: HK
authors.lastname: Chung
authors.affiliation: College of Pharmacy, Chungnam National University, Daejeon, 38430, Korea.
authors.forename: Jong-Seong
authors.initials: JS
authors.lastname: Kang
authors.affiliation: College of Pharmacy, Kangwon National University, Chuncheon, 24341, Korea. kyeong@kangwon.ac.kr.
authors.forename: Kyeong Ho
authors.identifier: http://orcid.org/0000-0002-6017-2256
authors.initials: KH
authors.lastname: Kim
mesh_terms: D002482:Cellulose; D002851:Chromatography, High Pressure Liquid; D057230:Limit of Detection; D054328:Proton Pump Inhibitors / Q000032:analysis*; D064750:Rabeprazole / Q000032:analysis*; D012015:Reference Standards; D015203:Reproducibility of Results; D013237:Stereoisomerism; D013607:Tablets / Q000032:analysis
chemical_list: D054328:Proton Pump Inhibitors; D013607:Tablets; D064750:Rabeprazole; D002482:Cellulose
keywords: Enantiomeric separation; Immobilized cellulose-based column; Rabeprazole; Validation