复方当归(冻干)注射剂的高效液相色谱指纹图谱研究

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

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。

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 （gelslccation）.