关键词: 气相色谱法, 奥氮平, 有机溶剂残留

Abstract: Objective To develop a method for the determination of five residual organic solvents in olanzapine. Methods The residual organic solvents including methanol, dichloromethane, ethanol, triethylamine and toluener were quantitatively determined by GC, and nitrogen was the carrier gas. Results Five residual organic solvents were completely separated. The linear range of methanol was 0.030 7-0.614 0 mg/mL(r=1), the linear range of ethanol was 0.051 9-1.038 0 mg/mL(r=0.999 7), the linear range of dichloromethane was 0.005 7-0.114 8 mg/mL(r=0.999 9), the linear range of triethylamine was 0.051 36-1.027 2 mg/mL(r=0.999 9), the linear range of toluener was 0.009 5-0.190 0 mg/mL(r=0.999 9). The theoretical plates of five organic solvents were much more than 5 000, the separation of the organic solvents was more than 2.0, the separation of the measured solvent and solvent blank was more than 2.0, system suitability and system precision are required. The RSDs of precision of six residual organic solvents were less than 5%, the average recovery rates of the preparation were in the range of 90%-100%. The RSDs of recovery were less than 2.0%. conclusion The method is simple, sensitive, accurate and can be used for the quality control of olanzapine.

Key words: GC, Olanzapine, residual organic solvents