摘要
目的:建立同时测定清开灵注射液中7个酚酸类成分(新绿原酸、绿原酸、隐绿原酸、咖啡酸、3,4-二咖啡酰奎宁酸、3,5-二咖啡酰奎宁酸、4,5-二咖啡酰奎宁酸)含量的方法。方法:采用Agilent Zorbax SB-C18色谱柱(250 mm×4.6 mm,5μm),流动相为0.1%甲酸水溶液(A)-乙腈(B),梯度洗脱,流速为0.5 mL·min-1,检测波长327 nm,柱温30℃。结果:80min内7个待测组分分离度良好,在各自的检测范围内与峰面积呈良好的线性,其相关系数均大于0.9998,加样回收率为96.1%～103.9%。应用所建立的方法同时测定了清开灵注射液中新绿原酸、绿原酸、隐绿原酸、咖啡酸、4,5-二咖啡酰奎宁酸、3,4-二咖啡酰奎宁酸、3,5-二咖啡酰奎宁酸共7个成分的含量,并对5个不同批次的注射液进行了含量测定,其结果有一定的差异。结论:本法可为清开灵注射液中酚酸类成分的质量控制提供参考。
Objective：To establish an HPLC -DAD method for simultaneous determination of 7 phenolic acids（neo- chlorogenic acid, chlorogenic acid, cryptochlorogenic acid, caffeic acid, 3,4 - dicaffeoylquinic acid, 3,5 - dicaf- feoylquinic acid and 4,5- dicaffeoylquinic acid） in Qingkailing injection. Methods：The separation was achieved on an Agilent Zorbax SB -C18 analytical column（250mm×4.6mm,5μm） with a gradient elufion of 0. 1% formic acid（A） and acetonitrile （B） at a flow rate of 0. 5 mL . min -1. The detection wavelength was 327 nm and the column temperature was 30 ℃. Results：Perfect chromatogram with good separation was obtained within 80 min. All the seven calibration curves showed good linearity between concentration of each compound and peak area. And the value of r was higher than 0. 9998 for all the analytes. The recoveries were 96. 1% - 103. 9%. The developed method was successfully applied for the simultaneous determination of the 7 components （neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid, caf- feie acid, 4,5- dicaffeoylquinie acid, 3,4- dicaffeoylquinic acid and 3,5- dieaffeoylquinic acid） in Qingkailing injec- tion of five different batches which had great variation on the determination results. Conclusion： The developed method can provide reference for quality control of phenolic acids in Qingkailing injection.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2013年第1期73-77,共5页
Chinese Journal of Pharmaceutical Analysis
基金
国家"重大新药创制"科技重大专项(2010ZX09502-002)
北京中医药大学自主选题项目资助(2011-JYBZZ-XS104)
