RP-HPLC法测定盐酸甲氧氯普胺注射液含量及有关物质

RP-HPLC determination of metoclopramide hydrochloride injection and its related substance

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 RP-HPLC method for determination of metoclopramide hydrochloride injection.Methods： Diamonsial C18 column（150 mm×4.6 mm,5 μm） was adopted with the mobile phase of acetonitrile-0.025 mol·L-1 ammonium acetate（including 0.2% triethylamine,adjusted to pH 5.7 with glacial acetic acid）（20∶80） at a flow rate of 1.0 mL·min-1;The detection wavelength was 275 nm and the column temperature was 30 ℃.Results：The calibration curve was linear in the range of 10-300 μg·mL-1（r=0.9997）,and the limit of detection was 1 ng.Conclusion：The method is simple,accurate and sensitive,and can control the quality of the preparation effectively.