摘要
目的:建立以高效液相色谱法测定甲氧氯普胺中有关物质含量的方法。方法:色谱柱为C18,流动相为乙腈-0.02mol.L-1磷酸溶液(19∶81),流速为1.0mL.min-1,检测波长为275nm,柱温为室温,进样量为20μL;以主成分自身对照法计算有关物质的含量。结果:在该色谱条件下,甲氧氯普胺与杂质能完全分离;杂质限量在0.05%～4.0%范围内测得的峰面积与样品自身对照溶液的浓度呈良好的线性关系;甲氧氯普胺的最小检出量为0.3ng,其有关物质的含量均小于0.26%。结论:本方法简便、准确、灵敏度高、专属性强,可用于甲氧氯普胺中有关物质的检测。
OBJECTIVE： To establish an HPLC method for the determination of the contents of the related substances in metoclopramide. METHODS： The sample was separated on C18 column with the mobile phase consisted of acetonitrile - 0.02 mol·L^-1 phosphonic acid solution （19 ： 81） at a flow rate of 1.0 mL·min^-1. The detection wavelength was set at 275 nm; the column temperature was kept under room temperature and the injected volume was 20μL. The contents of the related substances in metoclopramide were computed by self - control method of main constituent. RESULTS： Under the above described chromatographic conditions, metoclopramide was completely separated from its impurities. A good linearity between impurities＇ peak area and metoclopramide （contrast solution） concentration was achieved when the concentrations of impurities were over the range of 0.05%～4.0%. The lowest detectable limit of metoclopramide was 0.3 ng, and the contents of the related substances were all less than 0.26%. CONCLUSION： The method is convenient, accurate, sensitive and, specific, and it can be used for the determination of the related substances in metoclopramide.
出处
《中国药房》
CAS
CSCD
北大核心
2009年第13期1008-1010,共3页
China Pharmacy
基金
河北省科技攻关课题(07276426)
作者简介
田兰,副主任药师。研究方向：药物分析。电话：0311-852120048038。E-mail：tianlan921@sina．com
