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Chromatographic determination of polymerized impurities in meropenem.

Research paper by Shan-Ying SY Cai, Chang-Qin CQ Hu

Indexed on: 03 Mar '05Published on: 03 Mar '05Published in: Journal of Pharmaceutical and Biomedical Analysis



Abstract

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.