RP-HPLC gradient elution analysis for the determination of pantoprazole soldium and its related substances

Aim ：To establish a method for the determination of pantoprazole sodium and its related substances. Methods ：A column packed with octadecylsiance bonded silica gel(250 mm×4.6 mm，5 μm)was used.The 0.01 mol/L monopotassium phosphate solution(adjusted with phosphoric acid to pH 7.0)-acetonitrile were adopted as the mobile phase，a gradient elution was programmed as follows：0→30 min(90∶10→60∶40)，30→45 min(60∶40→15∶85)；the detection wavelength was 289 nm；the column temperature was 40 °C；the flow rate was 1.0 mL/min. Results ：Pantoprazole sodium，the intermediates and its related substances could be well separated.A good linear relationship was obtained over the range of 6.96-48.72 μg/mL(r=0.999 9). The limit detection and quantitation of pantoprazole sodium were 8.51 ng and 17.0 ng，respectively. Conclusion ：This method can be applied to control the related substances of pantoprazole sodium and determine pantoprazole sodium.