HPLC法测定甲氧氯普胺片中甲氧氯普胺及有关物质的含量

Content determination of metoclopramide and related substances for metoclopramide tablets by HPLC

目的建立测定甲氧氯普胺片中甲氧氯普胺及有关物质含量的方法。方法采用HPLC法。色谱柱为C18柱（250mm×4．0mm，5μm），流动相为乙腈-20mmol·L^-1磷酸溶液（体积比19：81，用三乙胺词pH值至4．0），流速为1．0mL·min^-1，检测波长为275nm。结果在建立的色谱条件下，甲氧氯普胺与杂质能完全分离；甲氧氯酱胺质量浓度在12．4～124mg·L^-1内与峰面积呈良好的线性关系，r=1．0000，平均回收率为100．5％（n=9）；有关物质（按甲氧氯普胺计）的检出限为0．3ng。结论HPLC法可用于甲氧氯普胺片的质量控制。

Objective To establish an HPLC method for the determination of content and related substances for metoclopramide tablets. Methods C18 column （250 mm × 4. 0 mm, 5 μm） was used with the mobile phase of acetonitrile-20 mmol·L^-1 phosphoric acid solution （ adjusting the pH to 4. 0 with triethylamine） （V：V=19：81）. The flow rate was 1.0 mL·min^-1 and the detection wavelength was set at 275 nm. Results Under the described chromatographic condition, metoclopramide was completely separated from its impurities. A linearity between peak area and metoclopramide concentration was achieved in the range of 12. 4-124 mg.L^-1 （ r = 1. 000 0） ,The average recovery（ n = 9） was 100. 5%. The limits of quantitation was 0. 3 ng. Conclusions The method is convenient, accurate, specific, sensitive and repeatable, and can be used for quality control of metoclopramide tablets.