Determination of Residual Solvent DMF in Imiquimod by HS-GC / 中国药师

ABSTRACT

Objective: To establish a new method for determining residual organic solvent DMF in imiquimod. Methods: The samples were injected into an Agilent HP-PLOT/Q capillary column(30 m × 0. 530 mm,40. 0 μm) by a headspace sampler and ana-lyzed with an FID detector, the carrier gas was nitrogen, the inlet temperature was 250℃, and the detector temperature was 270℃. The column temperature was programmed raised. Results: The resolution among the peaks of DMF and the other residual solvents could meet the requirements. There was a good linearity within the experimental concentration range. The average recovery was 94. 6%(RSD=4. 0%, n=9). The limit of quantification and the limit of detection was 4. 809μg·ml-1 and 0. 963μg·ml-1, respectively. Conclusion:The method is convenient, accurate and sensitive, which can be used in the determination of residual solvent DMF in imi-quimod.