Objective: To establish a method using gas chromatography for the determination of the residual chloroform in the medical polylactic acid membrane. Methods: The direct aqueous injection gas chromatographic method was established for the determination using RESTEK RTX capillary-column chromatography with the electron capture detector(ECD) at 270 ℃ and with the column at 85 ℃,maintained for 3 min. The split ratio of sampling was 10∶1. The injector temperature was 200 ℃. The high purity nitrogen was used as the carrier gas with the flow of 1. 0 ml /min. The injection volume was 1 μl. Results: The calibration curve showed a good linearity within the range of 25-2 000 ng /ml (r = 0. 999 9). The limit of detection was 1. 50 ng /ml,and the limit of quantitation was 4. 62 ng /ml. The average recovery rate was 98. 35％,RSD = 1. 98％. Conclusion: Gas chromatography is sensitive and accurate for the determination of the residual chloroform in the medical polylactic acid membrane.%目的: 建立医用聚乳酸薄膜中三氯甲烷残留量的测定方法.方法: 采用直接进样色谱法进行测定,使用RESTEK RTX毛细管色谱柱,检测器: 电子捕获检测器(ECD),检测器温度: 270 ℃,柱温: 85 ℃,维持3 min;分流进样方式,分流比: 10∶1;进样口温度: 200 ℃;载气: 高纯氮气,流速: 1. 0 ml /min;进样量: 1 μl.结果: 三氯甲烷在25 ～ 2 000 ng /ml范围内呈良好的线性关系(r = 0. 999 9);检测限为1. 50 ng /ml,定量限为4. 62 ng /ml;平均回收率为98. 35％,RSD = 1. 98％.结论:本实验方法灵敏、准确,可作为医用聚乳酸薄膜中三氯甲烷残留量的检测方法.
展开▼
