复方当归(冻干)注射剂的高效液相色谱指纹图谱研究

目的建立复方当归(冻干)注射剂的高效液相色谱指纹图谱。方法色谱柱为ZorbaxSB-C18(250mm×4.6mm,5μm),流动相为乙腈-0.25%磷酸溶液,采用梯度洗脱的方法进行色谱分离,流速为0.8mL.min-1,检测波长为300nm,柱温为30℃。结果确定了注射剂的21个共有峰,并得到了以阿魏酸为内标的相对保留时间及峰面积比值,非共有峰面积未超过总峰面积的5%。结论本方法简单可靠,可作为复方当归(冻干)注射剂的质量控制指标。

Study on the Fingerprint Chromatogram of Compound Angelica Injection (Gelsiccation) by HPLC

OBJECTIVE:To establish the fingerprint chromatogram of compounds Angelica injection (gelsiccation).METHODS:Zorbax SB-C18(250mm×4.6mm,5μm)column was used.The mobile phase consisted of acetonitrile-0.25%phosphoric acid and the gradient elution mode was applied in chromatographic separation.The flow rate was 0.8mL·min-1,the UV detection was performed at 300nm,and the column temperature was set up at 30℃.RESULTS:21 peaks were indicated on the HPLC fingerprint of compound Angelica injection (gelsiccation).The relative retention time and relative peak area were obtained with ferulic acid as internal standard.The area of uncommon peaks was no more than 5%of total peak areas.CONCLUSION:The method is simple,accurate and feasible for the quality control of compounds Angelica Injection (gelsiccation).