Abstract：Objective To establish a suitable method for determination of residual solvents in Cefpodoxime Proxetil. Methods Agilent DB-624 capillary column (30.0 m×0.25 mm×1.4 μm) was used, with FID detector, thirteen residual solvents (acetaldehyde, methanol, ethanol, isopropanol, dichloromethane, isopropyl ether, butanone, ethylacetate, tetrahydrofuran, cyclohexane, pyridine, toluene, butyl acetate) in Cefpodoxime Proxetil were determinated and analyzed by external standard method, internal standard method, standard addition method and correction factor standard addition method. Results The results showed that all residual solvents could be separated, and good linear relationships were obtained in their respective concentration ranges in the methods (r = 0.9980-1.0000), the detection limits were between 0.0250 to 0.3284 μg/mL. And significant differences recovery rates between all kinds of residual solvents, with the lowest recovery rates in acetaldehyde (39.7644%-42.1885%) and with the highest recovery rates in cyclohexane (125.3627%-132.2517%). Conclusion The standard addition method is the most suitable determination method for the residual solvents in Cefpodoxime Proxetil.
2017, Vol. 14 
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