摘要
目的建立HPLC法测定雷贝拉唑钠肠溶微丸的有关物质。方法采用Xtimate C18(4.6×150 mm,5μm)色谱柱,流动相采用2 g/L乙酸铵溶液-乙腈(95∶5)与2 g/L乙酸铵溶液-甲醇(15∶85),梯度洗脱,流速为1.0 mL/min,检测波长为290 nm。结果该色谱条件下,主成分与各已知杂质分离度良好。雷贝拉唑钠的检测限为0.25 ng,定量限为0.75 ng,为供试品进样量的0.01%和0.03%,满足杂质检测和控制。在选定的溶剂中,主成分能被有效提取且稳定性良好。在室温下,供试品溶液不稳定,应现用现配。结论方法简便、快速、准确,可用于雷贝拉唑钠肠溶微丸的质量控制。
Objective To establish an HPLC method for the determination of related substances of rabeprazole sodium.Methods The determination was performed on a Xtimate C18 column.The mobile phase consisted of 2 g/L ammonium acetate-acetonitrile （95：5）and 2 g/L ammonium-methanol（15：85）, with linear gradient elution and the flow rate of 1.0 mL/min.Detection wavelength was 290 nm.Results Related substances were completely separated from the main constituent.The limit of detection of rabeprazole was 0.25 ng and the limit of quantification was 0.75 ng,which were 0.01% and 0.03% of test sample and met the detection.With the selected solvents, principal component could be extracted efficiently and good stability.The sample solution was not stable at room temperature.Conclusion The method is simple, rapid and accurate, and can be used to control the quality of rabeprazole sodium enteric-coated pellets.
出处
《中国生化药物杂志》
CAS
2015年第4期165-168,共4页
Chinese Journal of Biochemical Pharmaceutics
