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.
ABSTRACT
Objective:To determine the residual formaldehyde fumigation on the surface of pharmaceutical equipments by AHMT method. Methods:The reaction time of AHMT was controlled in 20 min, the solution with sodium periodate was then shaken for 30 seconds and stood for 30 seconds, and then the absorbance at 550 nm was measured. Results: The linear range of formaldehyde was 0. 250~2. 495 μg·ml-1. The recovery of formaldehyde on glass plate, color steel plate and stainless steel plate was (83. 42 ± 1. 48)%(n=3), (83. 63 ± 1. 94)%(n=3)and (83. 94 ± 2. 28)%(n=3), respectively. Conclusion:The method is proved to be convenient and accurate, and is suitable for the determination of formaldehyde on the surface of pharmaceutical equipments.