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目的:建立HPLC测定盐酸甲氧氯普胺注射液含量和有关物质的方法。方法:色谱柱为DiamonsialC18(150 mm×4.6mm,5μm),乙腈-0.025 mol.L-1乙酸铵(0.2%三乙胺,冰醋酸调节pH至5.7)(20∶80)为流动相,流速1.0 mL.min-1,检测波长275 nm,柱温30℃。结果:本方法在10～300μg.mL-1范围内线性良好(r=0.9997),最低检测量1 ng。结论:本方法快速、灵敏,专属性强,适用于盐酸甲氧氯普胺注射液含量及其有关物质的测定。
Objective: To establish a HPLC method for the determination of metoclopramide hydrochloride injection and related substances. Methods: The mobile phase consisted of Diamonsial C18 (150 mm × 4.6 mm, 5 μm), acetonitrile-0.025 mol·L-1 ammonium acetate (0.2% triethylamine and glacial acetic acid adjusted to pH 5.7) 1.0 mL.min-1, detection wavelength 275 nm, column temperature 30 ℃. Results: The method was linear in the range of 10 ~ 300μg.mL-1 (r = 0.9997) with the lowest detection limit of 1 ng. Conclusion: The method is rapid, sensitive and specific. It is suitable for the determination of metoclopramide hydrochloride injection and its related substances.