跌打丸中非法染色剂金橙Ⅱ检测方法的改进

Improvement of the detection method of illegal staining agent golden orange Ⅱ in Dieda pills

目的:改进《中华人民共和国药典》2015年版一部跌打丸中非法染色剂金橙Ⅱ检测方法中液相色谱洗脱条件。方法:通过调整原方法洗脱梯度的时间,确定非法染色剂金橙Ⅱ的最佳峰型和保留时间。结果:改进色谱洗脱条件后金橙Ⅱ色谱峰峰型明显优于原方法。结论:改进后的液相色谱洗脱条件能使金橙Ⅱ对照品色谱峰峰型佳,分离度良好,供试品溶液中金橙Ⅱ出峰时间处无其他杂质峰干扰,专属性强,结果更稳定。

To Improve the elution conditions of liquid chromatography in the detection method of the illegal staining agent golden orangeⅡin the Dieda pills in the Chinese Pharmacopoeia 2015 edition.Methods:The optimal peak shape and retention time of the illegal stain golden orangeⅡwere determined by adjusting the time program of the elution gradient of the original method.Results:After improving the chromatographic elution conditions,the peak value of the golden orangeⅡpeak was significantly better than the original method.Conclusion:The improved liquid chromatography elution conditions could make the peak of the orange orangeⅡbetter,and the resolution was good.There was no other impurity peak interference at the peak time of the golden orangeⅡin the test solution and the specificity was strong.The result was more stable.