摘要
目的建立高效液相色谱法测定多潘立酮口腔崩解片的有关物质。方法采用反相高效液相色谱法。固定相为ODSC18色谱柱(5μm,4.6mm×150 mm)以甲醇-0.5%醋酸铵溶液(65∶35)为流动相,流速为1.0mL/m in,柱温室温。检测波长为286nm。结果经过酸、碱、热、光破坏,分解产物均能与主峰很好的分离。结论方法准确,专属性强,适用于多潘立酮口腔崩解片的有关物质测定。
OBJECTIVE To establish an HPLC method for the determination of the related substances of domperidone oraily disintergrating tablets. METHODS The RP-HPLC was performed on ODS C18 column（5μm,4.6mm × 150 mm） at room temperature, with mobile phase of methanol-0.5% acetic ammonium solution （65：35） at a flow rate of 1.0mL · min^-1 , and detection wavelength of 286nm. RESULTS Good resolution was obtained after the sample was destroyed by acid, alkali, heat and light. CONCLUSION The method is accurate and specific to analyze the related substances of dompefidone orally disintergrating tablets.
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2006年第2期165-166,共2页
Chinese Journal of Modern Applied Pharmacy
