热毒宁注射液及其中间体的HPLC指纹图谱

HPLC Fingerprints of Reduning Injection and Its Intermediates

建立了热毒宁注射液及其中间体I、II的高效液相色谱指纹图谱，可应用于注射液生产质量监控。采用DiamonsilC18色谱柱，以乙腈：0．1％甲酸为流动相，梯度洗脱，检测波长238nm。确定3种样品的共有峰数分别为22、23和24个；各样品指纹图谱的相似度均大于0．99；注射液与中间体化合物组成相关性良好，热毒宁注射液、中间体I和中间体II共有峰的相对峰面积的RSD范围分别为2．18％～8．48％、1．00％5．90％和1．17％～6．38％。结果提示，检测样品批间的共有成分与特征组分的相对峰面积的波动变化，可作为热毒宁注射液生产质量的监控方法。

The HPLC fingerprints and its application to quality control of Reduning injection and its intermediates I and II were established. A Diamonsil C18 column was used with the mobile phase of acetonitrile ： 0.1% formic acid by gradient elution, at the detection wavelength of 238 nm. There were 22, 23 and 24 common peaks for the above three samples, respectively. The similarities of Reduning injection samples and its intermediates were all above 0.99. The correlations of chemical compounds among Reduning injection and its intermediates were good. The RSD ranges of relative peak area of Reduning injection and its intermediates I and II were 2.18% - 8.48%, 1.00% - 5.90% and 1.17 % - 6.38 %. The results suggested that the variability of relative peak area of common components and feature components in different samples could be used for the quality control of Reduning injection.