HPLC法测定甲氧氯普胺片中甲氧氯普胺及有关物质的含量

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(250 mm×4.0 mm,5μm),流动相为乙腈-20 mmol.L-1磷酸溶液(体积比19∶81,用三乙胺调pH值至4.0),流速为1.0 mL.m in-1,检测波长为275 nm。结果在建立的色谱条件下,甲氧氯普胺与杂质能完全分离;甲氧氯普胺质量浓度在12.4~124 mg.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。

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

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. Conclusion The method is convenient, accurate, specific, sensitive and repeatable, and can be used for quality control of metoclopramide tablets.