高效液相色谱测定条件的耐用性试验研究

High-performance Liquid Chromatography Determination of Conditions for the Durability Test Study

目的:本研究以紫归敏康片中β,β′-二甲基丙烯酰紫草素含量测定确定的色谱条件为研究对象,考察其含量测定高效液相色谱(HPLC)条件的耐用性。方法:在不同的检测波长、流速、柱温、流动相配比、流动相PH、色谱柱等仪器条件下,对制剂中的指标性成分β,β′-二甲基丙烯酰紫草素进行含量测定。结果:在测试范围内,检测波长、流动相配比、流动相PH、色谱柱对含量测定无明显影响(RSD<3.0%),流速、柱温有较大影响(RSD>3.0%)。结论:通过耐用性试验考察,确定了含量测定色谱条件的适宜性,保证了含量测定的准确性、重现性和可信性。

Objective This study appearing in the film Purple β,β＇-dimethyl-propylene shikonin determination chromatography to determine the conditions for the study,visit the determination of high-performance liquid chromatography（HPLC） conditions for the durability.Method Determinate the agents in target composition of β,β＇-dimethyl-acrylamide content of shikonin under the condition of the detection of different wavelength,flow rate,temperature,the proportion of mobile phase,the PH of mobile phase,column.Results In the test,detection at the mobile than the match,the mobile phase PH,column,apparatus for the determination of no significant impact（RSD 3.0%）,flow rate,temperature influence（RSD 3.0%）.Conclusion Through the durability test study to determine the chromatographic determination of appropriate conditions,a determination to ensure the accuracy,reproducibility and credibility.