丹芪偏瘫胶囊中间体的HPLC/DAD/ELSD指纹图谱研究*

Study on the HPLC/DAD/ELSD fingerprint in intermediates of Danqi Capsule for Hemiplegia

关键词:  丹芪偏瘫胶囊  指纹图谱  中成药

Key words:  Hemiplegia Danqi Capsule  Fingerprint  HPLC/DAD/ELSD  Chinese medicine

摘要:

[目的]建立丹芪偏瘫胶囊中间体的高效液相色谱仪/二极管阵列检测器/蒸发光散射检测器(HPLC/DAD/ELSD)指纹图谱,为全面科学控制丹芪偏瘫胶囊的质量提供新方法。[方法]采用HPLC/DAD/ELSD串联技术,色谱柱:Waters Bridge柱,RP18(4.6mm×250mm,5.0μm)。流动相A:10%乙腈—冰醋酸(500:2.2,v/v),B:90%乙腈—冰醋酸(500:2.2,v/v),柱温:35℃,进样量:20μL,流速:1mL/min,检测波长:254nm;漂移管温度:50℃,加热器级别:68%,载气压力:35PSI,增益值:60。[结果]建立的方法对丹芪偏瘫胶囊中紫外吸收的成分和无紫外吸收的成分均有良好的分离,一次进样同时测定了两类不同成分的指纹图谱,不同批次间的相似度符合相关规定。[结论]该方法可用于丹芪偏瘫胶囊中间体中两类不同成分指纹图谱的同时测定。

Abstract:

[Objective] To establish the HPLC/DAD/ELSD fingerprint of Danqi Capsule for hemiplegia for the full scientific control of Danqi capsule hemiplegia and to provide a new method for the quality control.[Methods] The technique in series of HPLC/DAD/ELSD was applied.Waters Bridge,RP18 (4.6 mm×250 mm,5.0μm) were the column.The mobile phase:A:10%acetonitrile-aceticacid (500:2.2,v/v),B:10%acetonitrile-acetic acid (500:2.2,v/v).The flow rate was 1 mL/min,Wavelength detection at 254 nm,Drift tube temperature was 50℃,Heater level was 68%,Carrier gas pressure was 35PSI,Add value to 60.[Results] Based on the method established in the Experiment UV absorption and UV-free ingredients in Hemiparalysis Dan Capsules were well-separated,At the same time a sample was determined by two different components of the fingerprint,The similarity between different batches was able to meet the requirements.[Conclusion] This method can be used for hemiplegia Danqi Capsule intermediates in two different components of the fingerprint measured at the same time.