【摘要】 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。更多还原

【Abstract】 Panipenem exists as a mixture of two conformers (approximately 1∶1) in water. Due to the slow kinetics of the conformation change, the HPLC of panipenem may yield peak broadening or splitting and the poor resolution of related substances. In this study,the effects of the column temperature, pH, flow rate, silica gel, stationary phase and pairing ion on the peak profile and the separation of the panipenem conformers were investigated qualitatively. Results showed that the improvement of peak profile was favored by an increasement of column temperature or pH, adding of a positively charged pairing ion in the mobile phase. Conversely, the separation selectivity of conformers could be improved with decreasing column temperature or pH, increasing of flow rate and adding a negatively charged pairing ion in the mobile phase. Panipenem conformers could be separated on silica gel stationary phase. An HPLC system suitable to the determination of panipenem for injection was established.更多还原