高效液相色谱法同时测定清肝益脾胶囊中靛蓝和靛玉红含量  

Simultaneous Determination of Indigo and Indirubin in Qinggan Yipi Capsules by HPLC

作　　者：徐明昊 王斯琦 苏子衡 潘韵芝 程军平 XU Minghao;WANG Siqi;SU Ziheng;PAN Yunzhi;CHENG Junping(Suzhou Hospital of Traditional Chinese Medicine,Nanjing University of Chinese Medicine,Suzhou,Jiangsu,China 215000;The Fifth People's Hospital of Suzhou,Suzhou,Jiangsu,China 215000)

机构地区：[1]南京中医药大学附属苏州市中医医院,江苏苏州215000 [2]江苏省苏州市第五人民医院,江苏苏州215000

出　　处：《中国药业》2023年第12期88-90,共3页China Pharmaceuticals

基　　金：江苏省苏州市“科教兴卫”青年科技项目[KJXW2018044,KJXW2022048];江苏省苏州市科技发展计划项目[SKYXD2022099]。

摘　　要：目的建立同时测定清肝益脾胶囊中靛蓝和靛玉红含量的高效液相色谱法。方法色谱柱为Hypersil ODS柱(250 mm×4.6 mm,25μm),流动相为甲醇-水(70∶30,V/V),流速为1.0 mL/min,检测波长为290 nm,柱温为30℃,进样量为10μL。结果靛蓝和靛玉红质量浓度分别在7.63~122.00μg/mL、5.00~80.00μg/mL范围内与峰面积线性关系良好(R^(2)≥0.9998);精密度、稳定性、重复性试验结果的RSD均小于3.0%;平均加样回收率分别为96.93%和98.40%,RSD分别为1.36%和1.42%(n=6)。结论所建立的方法简便,结果准确,重复性好,可用于清肝益脾胶囊的质量控制。Objective To establish the high-performance liquid chromatography(HPLC)method for the simultaneous determination of indigo and indirubin in Qinggan Yipi Capsules.Methods The chromatographic column was Hypersil ODS column(250 mm×4.6 mm,25μm),the mobile phase was methanol-water(70∶30,V/V),the flow rate was 1.0 mL/min,the detection wavelength was 290 nm,the column temperature was 30℃,and the injection volume was 10μL.Results The linear ranges of indigo and indirubin were 7.63-122.00μg/mL and 5.00-80.00μg/mL respectively(R^(2)≥0.9998).The RSDs of precision,stability and repeatability tests were all lower than 3.0%.The average recovery rates of indigo and indirubin were 96.93%and 98.40%respectively,with RSDs of 1.36%and 1.42%respectively(n=6).Conclusion The established method is simple,accurate and repeatable,which can be used for the quality control of Qinggan Yipi Capsules.

关 键 词：清肝益脾胶囊 靛蓝 靛玉红 高效液相色谱法 含量测定 

分 类 号：R917[医药卫生—药物分析学] R927[医药卫生—药学]