优化并验证一种新的 CE 方法以测定泮托拉唑对映异构体。
Optimization and validation of a new CE method for the determination of pantoprazole enantiomers.
机构信息
School of Applied Chemistry, Shenyang University of Chemical Technology, Shenyang, China.
出版信息
Electrophoresis. 2012 Jun;33(11):1631-6. doi: 10.1002/elps.201100650.
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.
建立并验证了一种使用磺丁基醚-β-环糊精（SBE-β-CD）作为手性添加剂的新型 CE 方法，用于测定泮托拉唑对映异构体。优化了影响其分离效率的主要因素，包括手性选择剂、缓冲液 pH 值、有机添加剂和外加电压。使用由 50 mM 硼砂-150 mM 磷酸盐组成并调节至 pH 值 6.5、20 mg/mL SBE-β-CD 和外加 10 kV 电压的缓冲液可获得最佳结果。对优化方法进行了线性、精密度、准确度验证，结果表明该方法稳健。R-(+)-泮托拉唑的检出限和定量限分别为 0.9 和 2.5 μg/mL。该方法能够测定 S-(-)-泮托拉唑原料药中 R-对映异构体的最低限量为 0.1%（w/w）。
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