摘要
目的建立测定多司马酯中有关物质的HPLC方法。方法采用ODS C18柱;流动相为缓冲液(冰醋酸0.4 mL,三乙胺1.6 mL,加水400 mL,用磷酸调pH至7.5)-甲醇(72:28);检测波长330nm。结果样品在本色谱条件下,有关物质均能较好分离,在测定范围内有较好的线性关系及精密度。结论测定方法简便、准确可靠,可用于多司马酯有关物质的测定。
Objective To establish an RP-HPLC method for the determination of the related substances of dosmalfate. Methods The separation was performed with ODS C18 column. Glacial acetic acid 0.4mL and triethylamine 1.6 mL was dissolved with 400 mL water, adjusting pH to 7.5 with phosphoric acid. The mobile phase consisted of this solution-methanol(72:28). The detection wavelength was set at 330 nm. Results In this chromatography system, the related substances had a good separation and a good linear relation over the determination concentration. Conclusion This method is simple, accurate and applicable for the determination of related substances of dosmalfate.
出处
《食品与药品》
CAS
2012年第7期282-283,共2页
Food and Drug