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目的:选用合适的液相色谱条件,测定泮托拉唑钠原料药的含量。方法:采用RP HPLC法。色谱柱为LichrospherODSC8柱(4.6×2 0 0mm ,5 μm )。流动相为磷酸盐缓冲液(取Na2 HPO41.12g与NaH2 PO40 .18g ,加水溶解并稀释至10 0 0ml,加入0 .1%的正辛胺,用磷酸调pH值为7.0 ) -乙腈(6 5 :35 ) ,柱温35℃,流速1.0ml/min ,检测波长2 88nm。结果:此条件下实现基线分离,在一定范围内线性良好,精密度、回收率均较好。结论:本法简便快速,灵敏准确,方法可行。
Objective: To select the appropriate liquid chromatography conditions, determination of pantoprazole sodium API content. Methods: RP HPLC method was used. The column was a Lichrospher ODSC8 column (4.6 × 200 mm, 5 μm). The mobile phase was phosphate buffer (take Na2 HPO41.12g and NaH2PO40.18g, dissolved in water and dilute to 100ml, add 0.1% n-octylamine, adjust the pH to 7.0 with phosphoric acid) -acetonitrile (6 5:35), the column temperature 35 ℃, flow rate 1.0ml / min, detection wavelength of 2 88nm. Results: Baseline separation was achieved under these conditions. The linearity was good within a certain range, and the precision and recovery rate were all good. Conclusion: This method is simple, rapid and sensitive, accurate and feasible.