反相高效液相色谱法测定注射用埃索美拉唑钠有关物质

Determination of related substances in esomeprazole sodium for injection by RP-HPLC

目的建立RP-HPLC法测定注射用埃索美拉唑钠的有关物质。方法采用Inerstil ODS-3色谱柱（150mm×4.6 mm,5μm）,以乙腈-磷酸盐缓冲液（pH=7.4）-硫酸氢四丁基铵溶液（26：69：5）为流动相,柱温30℃,流速1.0 m L·min-1,检测波长为280 nm。结果主成分与各杂质之间良好分离,杂质A、B溶液冷藏避光24 h稳定,杂质C不稳定。奥美拉唑浓度在0.063 3-2.110 8μg·mL^-1（r=1.000）、杂质A浓度在0.146 5-1.953 8μg·mL^-1（r=1.000）、杂质B浓度在0.158 7-1.983 5μg·mL^-1（r=0.999 9）、杂质C浓度在0.057 6-3.838 8μg·mL^-1（r=0.999 6）与峰面积呈良好的线性关系。3种杂质的平均回收率均在91%-105%,RSD均〈5%,均符合要求。结论本方法可用于注射用埃索美拉唑钠的质量控制。

Objective To establish an RP-HPLC method to determine the related substances in esomeprazole sodium for injection. Methods The determination was performed on a Inerstil ODS-3 column（150 mm×4.6 mm, 5 μm）, with a mobile phase consisting of a mixture of acetonitrile and phosphate buffer（p H = 7.4） and tetrabutylammonium hydrogen sulfate. The column temperature was 30 ℃ at 1.0 mL·min^- 1 and the detective wavelength was 280 nm. Results The related substances were completely separated from the main constituent. Impurity A and B were stable in 24 h under the condition of frozen dark, but impurity C was not stable. Omeprazole and impurity A, B and C had good linearity at 0.063 3- 2.110 8 μg·mL^- 1（r = 1.000）, 0.146 5- 1.953 8 μg·mL^- 1（r = 1.000）, 0.158 7- 1.983 5 μg·mL^- 1（r = 0.999 9）, 0.057 6- 3.838 8 μg·mL^- 1（r = 0.999 6） respectively. The recoveries were at 91%- 105%, andRSDs were less than 5%, which could be meet the requirements. Conclusion The method can be used for the quality control of esomeprazole sodium for injection.