摘要
目的:建立泮托拉唑钠肠溶胶囊有关物质的测定方法。方法:采用色谱柱Kromasil C18(250 mm×4.6 mm,5μm),流动相以0.01 mol·L-1磷酸氢二钾溶液(用磷酸调节pH至7.0)-乙腈进行梯度洗脱,柱温为40℃,流速为1.0 ml·min-1,检测波长为289 nm,进样量为20μl。结果:泮托拉唑钠与降解产物均良好分离,最低检测限与最低定量限分别为0.16 ng和0.48 ng。结论:本法简便、专属,灵敏度高,可用于泮托拉唑钠肠溶胶囊的有关物质测定。
Objective： To establish a method for the determination of the related substances in pantoprazole sodium capsules. Methods： A Kromasil C18 column （250 mm × 4.6 mm, 5 μm） was used. 0.01 mol · L^-1 monopotassium phosphate solution （adjusting pH to 7.0 with phosphoric acid） -acetonitrile was adopted as the mobile phase with gradient elution. The detection wavelength was 289 nm and the column temperature was 40℃. The injection volume was 20 μl and the flow rate was 1.0 ml· min^-1. Results： Pantoprazole sodium and its degradation substances could be well separated. The limit of detection and quantification of pantoprazole sodium was 0.16 ng and 0.48 ng, respectively. Conclusion： The method is simple, specific and sensitive, and can be applied to determine the related substances in pantoprazole sodium.
出处
《中国药师》
CAS
2015年第6期943-945,共3页
China Pharmacist
