兽用原料药博普总碱的HPLC特征谱图的建立

Establishment of HPLC Characteristic Chromatogram for Veterinary Material Drug of Bopu Zongjian

关键词:  博普总碱  特征图谱  质量控制

Key words:  Bopu Zongjian  Characteristic Chromatogram  Quality Control

摘要:

建立HPLC特征谱图控制兽用原料药博普总碱的质量。HPLC 特征谱图包含4个特征峰，用对照品定性鉴别4个特征峰分别为原阿片碱、别隐品碱、血根碱和白屈菜红碱。考察检测波长、流动相条件、柱温、流速、色谱柱品牌对各特征峰相对保留时间的影响，确定优化后的高效液相条件，并具有良好的精密度、稳定性和重复性。分析15批博普总碱原料药的液相图谱，样品的相似度均大于0.95，并对特征峰的相对保留时间进行了规定，为原料药博普总碱质量控制提供了依据。

Abstract:

Established the HPLC characteristic chromatogram to control the quality of Bopu Zongjian. The HPLC characteristic chromatogram contains four characteristic peaks, and the four peaks identified by the reference substance are protopine, allocryptopine, sanguinarine and chelerythrine. Investigated the effects of detection wavelength, mobile phase conditions, column temperature, flow rate and column brand on the relative retention time of each characteristic peak, and the optimized HPLC conditions were determined to have good precision, stability and repeatability. Analyzed the HPLC characteristic chromatogram of 15 batches of Bopu Zongjian, the similarity of samples were greater than 0.95. Specified the relative retention time of characteristic peaks, which provided a reliable basis for the quality control of veterinary material drugof Bopu Zongjian.