Chromatographic determination of polymerized impurities in meropenem.
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.
Cai
Shan-Ying
SY
National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, PR China.
Hu
Chang-Qin
CQ
D002850:Chromatography, Gel / Q000379:methods*; D004340:Drug Contamination; D000077731:Meropenem; D011108:Polymers / Q000032:analysis* / Q000737:chemistry; D013845:Thienamycins / Q000032:analysis* / Q000737:chemistry
D011108:Polymers; D013845:Thienamycins; D000077731:Meropenem