气相色谱法测定新型口服液体药用复合硬片制瓶中12种残留溶剂

Determination of 12 Residual Solvents in New Oral Liquid Bottles Made of Composite Sheet for Preparation by Gas Chromatography

目的:建立气相色谱法测定新型口服液体药用复合硬片制瓶中12种残留溶剂。方法:采用HP-INNOWAX(60m×0.32mm×0.50μm)石英毛细管柱,进样口温度200℃,FID检测器温度220℃,氢气流量40mL·min^-1,氮气流量2mL·min^-1;空气流量400mL·min^-1;顶空温度100℃;顶空时间60min。结果:12种残留溶剂在0.0036μg^5.5488μg范围内线性良好,平均回收率83.31%~106.55%之间,RSD在1.98%~9.06%之间。结论:该方法准确可靠,检出限低,可用于新型口服液体药用复合硬片制瓶中12种残留溶剂的含量测定。

Objective:To establish a gas chromatography method for the determination of 12 kinds of residual solvents in new oral liquid bottles made of composite sheet for preparation.Methods:HP-INNOWAX(60m×0.32mm×0.50μm)quartz capillary column was used,the inlet temperature was 200℃,the FID detector temperature was 220℃,the hydrogen flow was 40mL·min^-1,and the nitrogen flow was 2mL·min^-1;air flow rate 400mL·min^-1;headspace temperature 100℃;headspace time:60min.Results:The 12 residual solvents had good linearity within 0.0036μg^5.5488μg,the average recovery was 83.31%~106.55%,and the RSD was 1.98%~9.06%.Conclusion:This method is accurate and reliable with low detection limit,and can be used for the determination of 12 kinds of residual solvents in new oral liquid bottles made of composite sheet for preparation.