关键词: font-size:medium, ">顶空气相色谱法；注射用美罗培南；残留溶剂；一致性评价

Abstract: Objective：The headspace-gas chromatography method was established for the determination of residual solvents in meropenem for injection as the supplementary for consistency evaluation. Through the investigation of organic solvent residues， the differences between the products of domestic manufacturers and the original drugs were effectively evaluated. Methods： The determination was performed on DB-624 capillary column using the flame ionization detector. The column temperature was 40 ℃. Results：The calibration curves of three organic solvents showed good linearity (r>0.999). The limit of quantification was 0.20-0.80 μg·mL-1 and the detection limits was 0.04-0.40 μg·mL-1. The average recovery was 90.79%-100.62%. Conclusion：The method with simple operation and accurate results cloud determine the residual solvents in meropenem for injection form different manufacturers and effectively judge the process difference between domestic products and RLD.

Key words: font-size:medium, ">Headspace-gas chromatography； Meropenem for injection； Residual solvents； Consistency evaluation