CAJ | 학술논문

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砄5）与2 g／L乙酸铵溶液-甲醇（15砄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。
목적：건립HPLC법측정뢰패랍서납장용미환적유관물질。방법채용Xtimate C18（4.6×150 mm，5μm）색보주，류동상채용2 g／L을산안용액-을정（95결5）여2 g／L을산안용액-갑순（15결85），제도세탈，류속위1.0 mL／min，검측파장위290 nm。결과해색보조건하，주성분여각이지잡질분리도량호。뢰패랍서납적검측한위0.25 ng，정량한위0.75 ng，위공시품진양량적0.01％화0.03％，만족잡질검측화공제。재선정적용제중，주성분능피유효제취차은정성량호。재실온하，공시품용액불은정，응현용현배。결론방법간편、쾌속、준학，가용우뢰패랍서납장용미환적질량공제。
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.