高效液相色谱法测定奥美拉唑肠溶胶囊的含量

Determination the Content of Omeprazole Enteric-coated Capsules by HPLC

目的:建立高效液相色谱法测定奥美拉唑肠溶胶囊含量的方法。方法:采用Diamonsil-C_(18)色谱柱(250 mm×4.6 mm,5μm),以甲醇-磷酸盐缓冲液(pH 7.6)(80:20)作流动相,流速1.0 ml·min^(-1),检测波长为302 nm。结果:奥美拉唑的线性范围为10～50μg,r=0.999 9,平均回收率为99.6%,RSD=1.36%。结论:本方法简便,快速,精密度好,可作为该制剂的质量控制。

Objective： To establish a HPLC method for determination the content of omeprazole enteric-coated capsules. Method ： The Diamonsil C18 （250 mm × 4.6 mm,5 μm） was used. methanol -phosphate butter（ pH 7.6） （80： 20） as mobile phase, the flow rate was 1.0 ml·min^-1, the detection wavelength was at 302 nm. Result： The linear range of omeprazole was 10 -50 μg（ r = 0.999 9）. the average recovery was 99, 60% （RSD = 1.36% ）. Conclusion： The method is simple, rapid, accurate and can be used for the quality control of omeprazole.