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目的:建立氟氯西林镁阿莫西林干混悬剂有关物质检查的HPLC方法.方法:采用Dikma Diamonsil-C18(4.6×250 mm,5μm),对氟氯西林镁和阿莫西林分别进行测定.氟氯西林镁的有关物质检查以磷酸盐缓冲液(pH5.0)-乙腈(67:33)为流动相;检测波长225nm;阿莫西林的有关物质检查以磷酸盐缓冲液(pH5.0)-乙腈(98:2)为流动相;检测波长254nm;柱温40℃.结果:各降解产物均可与主药进行良好分离,方法的专属性和精密度良好.结论:该方法准确、简便、快速,结果可靠.
OBJECTIVE: To establish HPLC method for the determination of related substances of amoxicillin suspension of flucloxacillin.METHODS: Determination of flucloxacillin magnesium and amoxicillin by Dikma Diamonsil-C18 (4.6 × 250 mm, 5μm) respectively. Fluoxacillin magnesium related substances check with phosphate buffer (pH5.0) - acetonitrile (67:33) as the mobile phase; detection wavelength of 225nm; amoxicillin related substances in phosphate buffer (pH5.0) - acetonitrile (98: 2) as mobile phase at a detection wavelength of 254 nm and a column temperature of 40 ° C.Results: All the degradation products were separated from the main drug, and the specificity and precision of the method were good.Conclusion: The method is accurate and simple Fast, reliable results.