Cai Shan-Ying, Hu Chang-Qin
National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, PR China.
J Pharm Biomed Anal. 2005 Mar 9;37(3):585-9. doi: 10.1016/j.jpba.2004.11.023. Epub 2004 Dec 24.
A method for the separation of polymerized impurities in meropenem has been developed by gel filtration chromatography (GFC). The chromatographic conditions included a Superdex peptide HR 10/30 column and the mobile phase consisting of 0.01 mol L(-1) sodium phosphate buffer (pH 7.0), at a flow rate of 0.8 mL min(-1). The wavelength of UV detector was set at 220 nm. The linear range was 0.08-10 microg (r=0.9998); relative standard deviation (R.S.D.)=0.5-1.5%; the LOD and LOQ were 2.4 and 12.4 ng, respectively. Specificity of the GFC was checked by switching the effluent of each peak on the GFC to a C18 trap column and analyzing the effluent by LC-MS. The result shows that for the determination of polymers, the gel filtration chromatography is a rather simple separation mode as compared to RPLC.
已开发出一种通过凝胶过滤色谱法（GFC）分离美罗培南中聚合杂质的方法。色谱条件包括使用Superdex peptide HR 10/30色谱柱，流动相为0.01 mol L(-1)磷酸钠缓冲液（pH 7.0），流速为0.8 mL min(-1)。紫外检测器的波长设定为220 nm。线性范围为0.08 - 10 μg（r = 0.9998）；相对标准偏差（R.S.D.）= 0.5 - 1.5%；检测限（LOD）和定量限（LOQ）分别为2.4 ng和12.4 ng。通过将GFC上每个峰的流出物切换至C18捕集柱并通过LC-MS分析流出物来检查GFC的特异性。结果表明，对于聚合物的测定，与反相高效液相色谱法（RPLC）相比，凝胶过滤色谱法是一种相当简单的分离模式。
