Determination of S-(−)-lansoprazole in dexlansoprazole preparation by capillary zone electrophoresis

• Published in: Archives of pharmacal research 2017, 40(8), , pp.962-971
• Main Authors: Chung, Hyun Kyu, Truong, Quoc-Ky, Mai, Xuan-Lan, Choi, Yusung, Kang, Jong-Seong, Mar, Woongchon, Kim, Kyeong Ho
• Format: Article
• Language: English
• Subjects: beta-Cyclodextrins - chemistry; Dexlansoprazole - analysis; Dexlansoprazole - chemistry; Electrophoresis, Capillary - methods; Lansoprazole - analysis; Lansoprazole - chemistry; Limit of Detection; Medicine; Pharmacology/Toxicology; Pharmacy; Proton Pump Inhibitors - analysis; Proton Pump Inhibitors - chemistry; Research Article; Stereoisomerism; 약학
• ISSN: 0253-6269; 1976-3786
• DOI: 10.1007/s12272-017-0936-8

Capillary zone electrophoresis was successfully applied to the enantiomeric purity determination of dexlansoprazole using sulfobutyl ether-β-cyclodextrin and methyl-β-cyclodextrin as chiral selectors. Separations were carried out in a 50 μm, 64/56 cm fused-silica capillary. The optimized conditions included 90 mM phosphate buffer, pH 6.0, containing 30 mM sulfobutyl ether-β-cyclodextrin, 20 mM methyl-β-cyclodextrin as background electrolyte, an applied voltage of 25 kV and a temperature of 16 °C, detection was at 280 nm. The assay was validated for the S-(−)-lansoprazole in the range of 0.2–1.0%. The limit of detection was 0.07%, the limit of quantitation was 0.20%, relative to a total concentration of 4.0 mg mL −1 . Intra-day precision varied between 1.72 and 2.07%. Relative standard deviations of inter-day precision ranged between 1.62 and 1.96% for peak area ratio. The assay was applied for the determination of the chiral purity of dexlansoprazole capsules. Recovery in capsules was ranged between 101.7 and 103.1%. Graphical Abstract