Author(s): Ma Jianfang, Zhu Yinghua, Ren Feiliang, Liu Wei, Peng Xingsheng, Chen Guiliang
Pages: 69-70,71
Year: 2015 Issue:  12
Journal: China Pharmaceuticals
Keyword:  Risperidone for Depot Suspension; residual organic solvents; capillary gas chromatography;
Abstract: Objective To establish a capillary gas chromatography method for the simultaneous determination of residual organic solvents including ethanol,ethyl acetate and benzyl methanol in Risperidone for Depot Suspension. Methods The DB-624 capillary chromato-graphic column was used with direct injection and the temperature program. The volume of injection was 3 μL. The inlet temperature was 220 ℃. FID was used as the detector with the temperature of 250 ℃. The carrier gas was helium and its flow rate was 1 mL/min. The residual amounts of organic solvents including ethanol,ethyl acetate and benzyl methanol in Risperidone for Depot Suspension were simultaneously detected. Results Ethyl acetate was taken as the internal standard for ethanol and ethyl acetate,and benzyl ethanol as the internal standard for benzyl methanol. The organic solvents mentioned above were completely separated. The linear relations were good with the correlation coefficients exceeding 0. 999. The recovery rates were 90% -110%. Conclusion The method is simple,highly sensitive,better reproducible,strongly specific,rapid and accurate,which is suitable for the determination of residual organic solvents in Risperidone for Depot Suspension.