注射器式过滤器滤膜材质对HPLC有关物质测定法的影响

Influence of syringe filter membrane materials on HPLC determination of related substances

目的:考察不同滤膜材质的注射器式过滤器对HPLC法有关物质测定的影响。方法:采用不同的色谱条件,分别进样相应的5种滤膜材质的注射器式过滤器过滤的溶液,记录色谱图,并对结果进行分析。结果:色谱条件Ⅰ采集的色谱图显示,尼龙材质的滤膜对相应溶液的色谱行为有影响;色谱条件Ⅱ采集的色谱图显示,聚醚砜和尼龙材质的滤膜对相应溶液的色谱行为均有影响,其中聚醚砜和1号尼龙材质影响较大;色谱条件Ⅲ采集的色谱图显示,5种滤膜材质对相应溶液的色谱行为均有影响,其中聚醚砜影响最大,2号尼龙影响较小。溶液中有机相比例越高,滤膜材质对其色谱行为的影响越大。结论:采用HPLC法测定有关物质时,建议选择合适滤膜材质的注射器式过滤器,以减少滤膜材质对色谱行为的影响。本文为HPLC法测定时注射器式过滤器滤膜材质的选择提供参考。

Objective： To investigate the influence of syringe filters with different materials on the determination of the related substances by HPLC. Methods： The sample solutions obtained with five syringe filters with different materials were injected under the different chromatographic conditions, the chromatogram was recorded, and the results were analyzed. Results： The chromatograms obtained under chromatographic condition I showed that the nylon filter membrane had the influences on the chromatographic behavior of the corresponding solution. The chromatograms ob- tained under chromatographic condition I1 showed that the polyether sulfone and nylon filter membranes had the influ- ence on the chromatographic behavior of the corresponding solutions, and polyether sulfone and No. 1 nylon materials had the maximal influences. The chromatograms obtained under chromatographic condition III showed that all the five filter membrane materials had the influences on the chromatographic behavior of the corresponding solutions, and polyether sulfone had the maximal influence, while No. 2 nylon had the minimal influence. The filter material had the more influence on the sample＇s chromatographic behavior with the higher proportion of organic phase in the sample solution. Conclusion： It suggested that syringe filter with suitable material was used when HPLC was used to determine the related substances in order to reduce the filter material＇s influence on chromatographic behavior. This method provided the reference for selection of filter material for syringe filter for HPLC determination.