HPLC法测定盐酸甲氧氯普胺注射液的含量及有关物质___

摘要 目的：建立高效液相色谱法测定盐酸甲氧氯普胺注射液的含量和有关物质。方法：采用C18色谱柱（4.0 mm×250 mm，5 μm） 以乙腈－0.02 mol•L-1磷酸溶液（用三乙胺调节pH至4.0）（19∶81）为流动相 流速：1.0 mL•min-1 检测波长：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 甲氧氯普胺浓度在12.4~124.0 μg•mL-1范围内线性关系良好， r=1.000 平均回收率为99.3%（n=9） 测定甲氧氯普胺的最小检出量为0.3 ng。结论：本方法简便、准确，灵敏度高，专属性强，可用于盐酸甲氧氯普胺注射液的质量控制。

Abstract Objective:To establish an HPLC method for the determination of content and related substances for metoclopramide dihydrochloride injection.Methods:C18 column（4.0 mm×250 mm，5 μm） was adopted with the mobile phase of acetonitrile-0.02 mol•L-1 phosphonic acid solution（adjusting pH to 4.0 with triethylamine）（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 12.4-124.0 μg•mL-1， with r of 1.000.The average recovery（n=9） was 99.3%.The lowest detectable amount was 0.3 ng.Conclusion:The method is convenient,accurate,specific and sensitive and can be used for quality control of Metoclopramide Dihydrochloride Injection.