摘要
目的:建立高效液相色谱测定枸橼酸莫沙必利片有关物质的方法。方法:采用C18柱(250 mm×4.6 mm,5μm),以0.05mol.L-1枸橼酸溶液(用氢氧化钠溶液调节pH至4.0)-乙腈(65∶35)为流动相,流速1.0 mL.min-1,检测波长为274 nm,自身对照法测定。结果:线性范围为0.502~4.016μg.mL-1,r2=0.9978,最低检测限为0.33 ng。结论:该方法准确、简便,可以用于枸橼酸莫沙必利片有关物质的测定。
Objective:To establish an HPLC method for the determination of related substances in mosapride citrate tablets.Methods:The separation was performed on C18Column(250 mm×4.6 mm,5 μm) with mobile phase consisted of 0.05 mol·L-1 citric acid(adjusted pH=4.0 with sodium hydroxide solution)-acetonitrile(65∶ 35)and the flow rate was 1.0 mL·min-1.The detection wave length was set at 274 nm.The content of related substance was calculated by self-control with main component.Results:The standard curve was linear within the range of 0.502-4.016 μg·mL-1(r2=0.9978) and the limit of detection was 0.33 ng.Conclusion:The method is accurate and simple for the determination of the related substances in mosapride citrate tablets.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2011年第12期2330-2332,共3页
Chinese Journal of Pharmaceutical Analysis