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HAN Jia-yi, ZHANG Yun, WANG Xin-yue. RP-HPLC gradient elution analysis for the determination of pantoprazole soldium and its related substances[J]. Journal of China Pharmaceutical University, 2009, 40(6): 531-534.
Citation: HAN Jia-yi, ZHANG Yun, WANG Xin-yue. RP-HPLC gradient elution analysis for the determination of pantoprazole soldium and its related substances[J]. Journal of China Pharmaceutical University, 2009, 40(6): 531-534.

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

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  • 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.

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