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作 者:明磊[1] 林美妤[1] 张庆贺[1] 刘海宇[1] 卢丹[1] 李平亚[1] 刘金平[1]
机构地区:[1]吉林大学再生医学科学研究所
出 处:《中国药房》2013年第7期639-641,共3页China Pharmacy
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.
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