摘要
目的:建立血栓心脉宁片的高效液相色谱(HPLC)-蒸发光散射检测器(ELSD)指纹图谱。方法:色谱柱为Diamonsil C18(250mm×4.6mm,5μm),柱温为40℃,流动相为乙腈-1%冰醋酸(梯度洗脱),流速为1.0ml/min,采用ELSD进行测定;应用中药色谱指纹图谱相似度评价系统(2004A版)进行评价。结果:10批血栓心脉宁片的HPLC-ELSD指纹图谱有17个共有峰,精密度、重复性、稳定性试验中各共有峰的相对峰面积与相对保留时间的RSD均<4%;10批样品的相似度在0.880～1.000之间。结论:本方法简便、准确、重复性好,可用于血栓心脉宁片的质量控制,可为血栓心脉宁片的深入研究提供基础。
OBJECTIVE： To establish fingerprint of Xueshuan xinmaining tablet by using HPLC-ELSD. METHODS： The anal- ysis was performed on Diamonsil C18 column （250 mm×4.6 mm, 5 μm） with mobile phase consisted of acetonitrile-1% acetic acid （gradient elution） at the flow rate of 1.0 ml/min. ELSD method was used; the data were analyzed by chromatographic fingerprint evaluation system （2004A version）. RESULTS： 17 common peaks were found in HPLC-ELSD fingerprints of 10 batches of Xuesh- uan xinmaining tablet. In precision, reproducibility and stability test, RSDs of relative peak area and relative retention time of com- mon peaks were less than 4%. The similarities of 10 batches of samples were between 0.880 and 1.000. CONCLUSION： The meth- od is simple, accurate and reproducible, and it is suitable for the quality control of Xueshuan ximnaining tablet. It provides basis for the further study of Xueshuan xinmaining tablet.
出处
《中国药房》
CAS
CSCD
2013年第7期639-641,共3页
China Pharmacy
