论文部分内容阅读
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(4.0mm×250mm,5μm);以乙腈-0.02mol·L-1磷酸溶液(用三乙胺调节pH至4.0)(19∶81)为流动相;流速:1.0mL·min-1;检测波长: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;甲氧氯普胺浓度在12.4～124.0μg·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0.3ng。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。
Objective: To establish a method for the determination of metoclopramide hydrochloride injection and its related substances by high performance liquid chromatography. Methods: C18 column (4.0mm × 250mm, 5μm) was used. The mobile phase consisted of acetonitrile-0.02mol·L-1 phosphoric acid solution (adjusted to pH 4.0 with triethylamine) (19:81) min-1; detection wavelength: 275nm. Results: Under the established chromatographic conditions, metoclopramide was completely separated from impurities. Metoclopramide concentration ranged from 12.4 to 124.0 μg · mL-1 with good linearity (r = 1.000) and the average recovery was 99.3 % (n = 9). The minimum detectable amount of metoclopramide was 0.3 ng. Conclusion: The method is simple, accurate, sensitive and specific. It can be used for the quality control of metoclopramide hydrochloride injection.