UHPLC与HPLC同时测定九味羌活丸5种物质含量的方法转换与比较分析  

Method Comparison and Conversion of the UHPLC and HPLC Methods for Determination of Five Sub-stances in Jiuwei Qianghuo Pills

作　　者：刘晶晶[1] 胡晓茹[1] 戴忠[1] 姚令文[1] 马双成[1] LIU Jing-jing;HU Xiao-ru;DAI Zhong;YAO Ling-wen;MA Shuang-cheng(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药学杂志》2021年第22期1818-1823,共6页Chinese Pharmaceutical Journal

摘　　要：目的建立同时测定九味羌活丸中升麻素苷、黄芩苷、汉黄芩苷、异欧前胡素及苍术素5种物质含量的亚超高效液相色谱(UHPLC)与HPLC,分析比较UHPLC与HPLC方法转换。方法两方法均使用流动相:甲醇-0.15%磷酸溶液梯度洗脱,检测波长248、275、310 nm,柱温35℃。结果UHPLC与HPLC测升麻素苷、黄芩苷、汉黄芩苷、异欧前胡素及苍术素在一定范围内呈现良好线性,r>0.9998,方法学考察良好,样品测定结果无显著性差异。UHPLC每份样品测定时间节省45 min,溶剂使用量节省至1/5倍。结论测定九味羌活丸此5种物质时,二者方法可以互换。与HPLC法相比,UHPLC法测定样品含量准确率高、灵敏度高、分离度好,具有高分析速度和低溶剂耗费优势,有利于提高实验室工作效率。OBJECTIVE To establish UHPLC and HPLC methods for determination of five related substances(prim-O-glucosylcimifugin,baicalin,wogonoside,isoimperatorin,and atractylodin)in Jiuwei Qianghuo pills and compare the two methods as well as the determination results.METHODS The mixture of methanol and 0.15%phosphoric acid was used as mobile phase in gradient elution mode.The detection wavelengths were set at 248 nm,275 nm,and 310 nm,and the column temperature was maintained at 35℃in both methods.RESULTS The linear relationships between the concentration and peak area of the five compounds were all good(r>0.9998).The methodology validation result was acceptable.There was no significant difference between the detection results of the two methods.The assay time of each sample of UPLC is 45 min,which is less than that of HPLC method,and the amount of solvent used is one fifth of that of HPLC method.CONCLUSION The two methods can be interchanged for the determination of the five substances in Jiuwei Qianghuo pills.Compared with the HPLC method,the UHPLC method has the advantages of high accuracy,high sensitivity and good separation.It has the advantages of high analysis speed and low solvent consumption,which is beneficial to improve the work efficiency of the laboratory.

关 键 词：亚超高效液相色谱法 高效液相色谱法 九味羌活丸 方法转换及验证 

分 类 号：R917[医药卫生—药物分析学]