关键词: font-size:13.3333px, ">枸地氯雷他定；原料药；顶空气相色谱法；残留溶剂

Abstract: Objective： To establish a method for determination of 12 residual organic solvents in desloratadine citrate disodium raw materials by different synthetic processes. Methods： Headspace gas chromatography（HS-GC） was adopted. The determination was performed on Agilent DB-624 (30 m×0.25 mm， 1.4 μm) capillary column using the temperature programming. The temperature of injector port was 250 ℃， and the FID detector was used with the temperature of 300 ℃. The carrier gas was nitrogen and the flow rate was 1.0 mL·min-1.The spilt ratio was 50：1， and the headspace injection volume was l.0 mL. The headspace equilibrium temperature was 90 ℃， and the equilibrium time was 30 min. Results： All the compounds were separated completely. The calibration curve of each compounds showed a good linear relationship with good precision and accuracy. Conclusion： The method is simple， sensitive and accurate， which can be applied on the organic solvent residue control of desloratadine citrate disodium raw material in different synthetic processes.

Key words: font-size:13.3333px, ">Desloratadine citrate disodium； Raw material； Headspace gas chromatography（HS-GC）； Residual solvents