摘要
目的建立高效液相色谱法,测定雷贝拉唑钠肠溶片的含量及有关物质。方法采用ZORBAX SB-C18(4.6×250 mm,5μm)色谱柱,以0.05 moL.L-1磷酸二氢钾溶液(以氢氧化钠试液调pH7.0)-甲醇(40∶60)为流动相,检测波长为285nm,流速为1.0 mL.min-1,柱温为35℃。结果雷贝拉唑钠浓度在0.002～0.01g.L-1内有良好的线性关系,r=0.9999。平均回收率为99.64%,RSD=0.522%。检测限为1.52×10-8g.L-1。结论本法简便、准确,灵敏度高,适用于雷贝拉唑钠肠溶片的质量控制。
OBJECTIVE To establish an HPLC method for the determination of rabeprazole in Rabeprazole Sodium Enteric-coated Tablets and its related substances.METHODS A stable HPLC method was established on a ZORBAX SB-C18 column（4.6×250mm,5μm）,the mobile phase consisted of 0.05mol·L-1 potassium dihydrogen phosphate,（adjusted PH7.0 with sodium hydroxide）-methanol（40∶60）,the detection wavelength was 285nm,the flow rate was 1.0mL·min-1The column temperature was 35℃.RESULTS A good linear relationship was observed in the concentration range of 0.002～0.01g·L-1 with the correlation coefficient of 0.9999,the average recovery was 99.64%,RSD=0.522%.CONCLUSION The method was simple,accurate and sensitive,and it was suitable for the quality control of Rabeprazole Sodium Enteric-coated Tablets.
出处
《齐鲁药事》
2010年第8期472-474,共3页
qilu pharmaceutical affairs
关键词
高效液相色谱法
雷贝拉唑钠肠溶片
含量
有关物质
HPLC
Rabeprazole Sodium Enteric-coated Tablets
Determination
Related substance
