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目的:建立阿莫西林分散片中有关物质的检测方法。方法:采用HPLC法,以十八烷基硅烷键合硅胶为填充剂;以0.05 mol/L磷酸盐缓冲液(pH=5.0)-乙腈(99:1)为流动相A;以0.05 mol/L磷酸盐缓冲液(pH5.0)-乙腈(80:20)为流动相B,梯度洗脱,流速为每分钟1.0 m l;检测波长为254 nm。结果:阿莫西林的检测限为20 ng,主成分与酸、碱、热、高温、光照和氧化降解形成的有关物质能有效分离。结论:该方法灵敏,可靠,计算简单,可用于阿莫西林分散片的有关物质检测。
Objective: To establish a method for the determination of related substances in amoxicillin dispersible tablets. METHODS: The elution was carried out by HPLC using octadecylsilane bonded silica as the filler. The mobile phase A was eluted with 0.05 mol / L phosphate buffer (pH = 5.0) - acetonitrile (99: 1) Phosphate buffer (pH5.0) -acetonitrile (80:20) was used as mobile phase B and gradient elution was performed at a flow rate of 1.0 ml / min. The detection wavelength was 254 nm. Results: The detection limit of amoxicillin was 20 ng. The main components were effectively separated from the related substances formed by acid, alkali, heat, high temperature, light and oxidative degradation. Conclusion: The method is sensitive, reliable and simple to calculate. It can be used to detect the related substances of amoxicillin dispersible tablets.