Gallinella Bruno, Ferretti Rosella, Zanitti Leo, Sestili Isabella, Mosca Antonina, Cirilli Roberto
Istituto Superiore di Sanità, Dipartimento del Farmaco, Viale Regina Elena 299, I-00161 Rome, Italy.
J Pharm Anal. 2016 Apr;6(2):132-136. doi: 10.1016/j.jpha.2015.11.001. Epub 2015 Nov 6.
A simple analytical high-performance liquid chromatography (HPLC) method was applied for the enantiomeric excess determination of esomeprazole (()-OME), the enantiopure active ingredient contained in drug products, in the presence of its potential organic impurities A-E. The enantioselective separation was accomplished on the immobilized-type Chiralpak ID-3 chiral stationary phase (CSP) under reversed-phase conditions. The results were evaluated and compared with those obtained by the official enantioselective method of European Pharmacopoeia used as the reference for checking the enantiomeric excess of ()-OME. It has been established that the use of the Chiralpak ID-3 CSP allows the determination of the enantiomeric purity of ()-OME without any interference coming from its chiral and achiral related substances. The analytical procedure of the drug regulatory agencies based on the AGP CSP suffered instead from poor specificity due to overlap of the peaks pertinent to the achiral impurity A and the chiral impurity ()-OME (impurity F).
应用一种简单的分析型高效液相色谱（HPLC）方法，在存在潜在有机杂质A - E的情况下，测定药物产品中对映体纯的活性成分埃索美拉唑（()-OME）的对映体过量。对映体选择性分离是在反相条件下，于固定型Chiralpak ID - 3手性固定相（CSP）上完成的。对结果进行了评估，并与采用欧洲药典官方对映体选择性方法获得的结果进行了比较，后者用作检查()-OME对映体过量的参考。已经确定，使用Chiralpak ID - 3 CSP能够测定()-OME的对映体纯度，而不会受到其手性和非手性相关物质的任何干扰。相反，基于AGP CSP的药品监管机构分析程序因非手性杂质A和手性杂质()-OME（杂质F）的峰重叠而特异性较差。
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