美罗培南有关物质的LC-MS分析

建立了HPLC梯度冼脱方法和质谱条件,对美罗培南水溶液的降解产物进行定性分析,推测出降解产物的化学结构式和降解途径。结果表明,美罗培南水溶液主要产生4个杂质峰,杂质Ⅰ在美罗培南主峰之前出峰,是美罗培南的开环降解物,杂质Ⅱ、Ⅲ和Ⅳ在美罗培南主峰之后出峰,是美罗培南的二聚体。中国药典的等度洗脱方法仅能检出前三个杂质峰,不能检出杂质Ⅳ。本文为进一步完善美罗培南的质量标准和提高临床用药的安全性提供依据。

LC-MS Analysis of Related Substances in Meropenem

The gradient elution method of HPLC and conditions of mass spectra were established,and the degradation products of meropenem solution were qualitatively analyzed,and the chemical structural formula and degradation pathway of degradation products were conjectured.The results showed that meroperem solution mainly produced four impurities,and impurities I eluted before the main peak of meroperem,that was the ring opening degradants of meroperem,and impuritiesⅡ,ⅢandⅣeluted after the main peak of meroperem,that were dimmer of meroperem. The isocratic elution method of Chinese Pharmacopiea could only detect the first three impurities except the 4th impurity.This method can provide the basis for further perfection of quality standard of meropenem and improvement on safety of clinical medications.