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KMID : 0043320170400030373
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Archives of Pharmacal Research
2017 Volume.40 No. 3 p.373 ~ p.381
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Determination of rabeprazole enantiomers in commercial tablets using immobilized cellulose-based stationary phase
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Kim Mi-Ri
Yu Su-Kyung
Truong Quoc Ky
Mai Xuan Lan
Chung Hyun-Kyu
Kang Jong-Seong
Kim Kyeong-Ho
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Abstract
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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.
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KEYWORD
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Rabeprazole, Enantiomeric separation, Immobilized cellulose-based column, Validation
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