注射用丹红(粉针剂)色谱指纹图谱研究

Study on chromatographic fingerprint of Danhong injectable powder

目的:建立注射用丹红(粉针剂)HPLC色谱指纹图谱。方法:采用RP-HPLC法,以原儿茶醛为内参照物,色谱柱:Luna C_(18)柱(250mm×4.6mm,5μm),流动相:0.05%磷酸水溶液(A)-乙腈(B),梯度洗脱程序为:0min时A-B(100∶0),80min时A-B(67∶33),85min时A-B(60∶40),100min时A-B(60∶40),流速:1.0mL·min^(-1),检测波长:280nm。结果:在色谱指纹图谱中,确定了19个共有峰,建立了注射用丹红(粉针剂)共有模式,各批丹红(粉针剂)与共有模式相似度均在0.99以上。结论:该方法简便、准确,重复性好,为注射用丹红(粉针剂)的质量控制提供了依据。

Objective：To establish HPLC chromatographic fingerprint of Danhong injectable powder. Methods ：The RP - HPLC method was applied and protocatechuic aldehyde was used as the internal standard substance. The separation was performed on a Luna C18 analytical column（250 mm ×4.6mm,5μm） with the mobile phase consisting of 0. 05% phosphoric acid （A） and acetonitrile （B） with gradient elution mode at the flow rate of 1.0 mL · min^-1 The following gradient procedure was used ：0→80 min ,0% →33% B ;80→85 min, 33% →0% B ;85→100 min, 40% B. The detection was set at 280 nm. Results：Selecting 19 peaks on the chromatographic fingerprint of Danhong injectable powder, the mutual model of injectable powder was established and the similarities were calculated. The results were all more than 0. 99. Conclusion：The method is simple and accurate with a good reproducibility and can be used as a quality control method for Danhong injectable powder.