碘海醇中3-氯-1,2-丙二醇测定方法的改进 |
| |
引用本文: | 郑金琪,应澄澄,付丽娜,郑国钢.碘海醇中3-氯-1,2-丙二醇测定方法的改进[J].中国药品标准,2013,14(6):437-439. |
| |
作者姓名: | 郑金琪 应澄澄 付丽娜 郑国钢 |
| |
作者单位: | 浙江省食品药品检验研究院;浙江司太立制药有限公司 |
| |
摘 要: | 目的:建立毛细管柱GC法测定碘海醇中3-氯-1,2-丙二醇残留量的方法。方法:采用OV-1701石英毛细管柱(30m×0.32mm×1.0μm),氢火焰离子化检测器,程序升温,进样口温度230℃,检测器温度250℃。结果:3-氯-1,2-丙二醇在4.982~398.6μg·mL^-1浓度范围内与峰面积呈良好的线性关系(r=0.9997,n=7),加样回收率为80.0%(RSD=6.6%,n=15);系统适用性溶液回收率应在60%-90%之间,分析了3批样品,第一批样品中未检出,第二批样品中含量为0.0030%,第三批样品中含量为0.0104%。结论:本法专属性强,灵敏度高,结果准确,可很好地控制碘海醇中3-氯-1,2-丙二醇的残留量。
|
关 键 词: | 碘海醇 3-氯 1,2 丙二醇 气相色谱法 |
收稿时间: | 2013/4/22 0:00:00 |
Improvement of Test Method on 3-chloro-1,2-propanediol in Iohexol |
| |
Authors: | Zheng Jinqi Ying Chengcheng Fu Lina and Zheng Guogang |
| |
Institution: | Zheng Jinqi;Ying Chengcheng;Fu Lina;Zheng Guogang;Zhengjiang Institute for Food and Drug Control;Zhejiang Starry Pharmaceutical Co.,Ltd; |
| |
Abstract: | Objective: To establish a GC method for the determination of 3-chloro-1,2-propanediol content in Iohexol. Methods: OV- 1701 quartz capillary column(30 m ×0. 32 mm × 1.0 μm) and FID were used. The column temperature was programmed, the inlet temperature was 230℃ and the detector was 250 ℃. Results:The standard curve of 3-chloro-1,2-propanediol had a good linear relationship in the range of 4. 982-398. 6 μg· mL- 1 (r = 0. 9997, n = 7), the average recovery was 80.0% ( RSD = 6.6% ,n = 15). The recovery of system suitability solution should be within 60% -90%. Three batches of samples were analyzed and the contents of 3-chlo- ro-1,2-propanediol were none, 0. 0030% and 0. 0104%, separately. Conclusion:The method provided a selective, sensivie and accurate feasible way for controlling the amout of 3-chloro-1,2-propanediol in Iohexol. |
| |
Keywords: | Iohexol 3-chloro-1 2-propanediol GC |
本文献已被 CNKI 维普 等数据库收录! |
| 点击此处可从《中国药品标准》浏览原始摘要信息 |
| 点击此处可从《中国药品标准》下载免费的PDF全文 |
|