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奥美拉唑镁肠溶片含量测定方法的改进

     

摘要

目的:建立高效液相法测定奥美拉唑镁肠溶片含量的方法.方法:采用Diamonsil-C18(4.6 mm×150 mm,5μm)色谱柱;流动相:甲醇-水-磷酸-三乙胺(65∶35∶0.12∶0.3);检测波长:302 nm;流速:1.0 ml/min.结果:奥美拉唑镁在13.3182~31.0758μg范围内与峰而积呈良好的线性关系(r=0.999 0),平均回收率为101.14%,RSD=1.64%.结论:本法简便、准确、重现性好,可用于奥美拉唑镁肠溶片的质量控制.%Objective: To establish a method for the content determination of Omeprazole Magnesium in Omeprazole Mag nesium Enteric-coated Tablets by HPLC. Methods: The Diamonsil-C18 (4.6 mm×150 mm, 5 μm) column was used. The mo bile phases consisted of methanol, water, phosphoric acid and triethylamine (65:35:0.12:0.3), the flow rate was 1.0 ml/min and the detection wavelength was at 302 nm. Results: The linear ranges of Omeprazole was at 13.318 2-31.075 8 μg (r=0.999 0),the average recovery was 101.14% with a RSD of 1.64%. Conclusion: The method is fast, reliable, accurate and can be used in the quality control of Omeprazole Magnesium in Omeprazole Magnesium Enteric-coared Tablets.

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