高效液相色谱法测定注射用雷贝拉唑钠的含量

Determination of Sodium Rabeprazole for Injection by HPLC

目的:建立注射用雷贝拉唑钠的含量测定方法。方法:采用高效液相色谱法,色谱柱:HypersilC18柱(4.6mm×250mm,5μm),流动相:磷酸盐缓冲液(取磷酸氢二钠1.119g和磷酸二氢钠0.179g,加水溶解并稀释至1000mL,摇匀)-乙腈(72:28);检测波长为:286nm;流速:1.0mL.mL-1。结果:雷贝拉唑钠在20.1～201.0μg·mL-1浓度范围内线性关系良好(r=0.9999),平均回收率为99.2%(RSD=0.49%)。结论:该方法简便快速,结果准确、可靠,可用于该制剂的含量测定。

Objective： To establish a method to determine the content of sodium rabeprazole for injection. Methods.. HPLC was applied, a Hypersil C18 column（4. 6mm×250mm, 5μm） was used, the mobile phase was phosphate buffer（sodium hydrogen phosphate 1. 119 g, sodium dihydrogen phosphate 0. 179 g, dissolved with water to 1000 mL, shaken）- acetonitrile （72：28）, the UV detecting wavelength was 286 nm, the flow rate was 1.0 mL · min^-1. Results. The linear relationship was fairly good when the concentration of sodium rabeprazole was within the range of 20. 1-201.0μg · mL^-1 （r=0. 9999）. The average recoveries of costunolide was 99.2%（RSD=0. 49G）. Conclusion： This method was proved to be simple and rapid, the result was accurate ,reliable and it can be used for the quality control of Sodium Rabeprazole for injection.