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由于帕尼培南在水溶液中以一对构象异构体 (约 1∶1 )的形式存在 ,因此在某些色谱系统中 ,因构象异构体在色谱过程中相互间转化的速率较低 ,导致帕尼培南峰展宽甚至裂分 ,并与有关物质的分离较差。本文定性地研究了柱温、pH、流速、硅胶、固定相和对离子等对帕尼培南峰形和构象异构体分离的影响。结果显示 ,提高柱温或pH ,流动相中添加荷正电的对离子 ,均可改善帕尼培南峰形 ;反之 ,降低柱温或 pH ,增加流速 ,流动相中添加荷负电的对离子 ,均有利于构象异构体的分离。硅胶对构象异构体具有分离能力。在此研究基础上初步提出了适用于注射用帕尼培南含量测定的HPLC系统。
Since panipenem exists as a pair of conformers (about 1: 1) in aqueous solution, the conformational isomers may have a lower rate of conversion to each other during chromatographic processes in some chromatographic systems, Leading to panipenem peak broadening and even split, and the separation of the relevant substances less well. This paper qualitatively studied the effects of column temperature, pH, flow rate, silica gel, stationary phases and counter ions on the separation of peak and conformer isomers of panipenem. The results showed that the increase of column temperature or pH and the addition of positively charged counterion to the mobile phase could improve the shape of panipenem. On the other hand, the column temperature or pH was decreased and the flow rate was increased. The mobile phase was charged with negatively charged ions, Conducive to the separation of conformers. Silica gel has the ability to separate conformers. On the basis of this study, the HPLC system suitable for the determination of panipenem for injection was initially proposed.