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RP-HPLC梯度洗脱法测定泮托拉唑钠的有关物质及含量

韩加怡, 张昀, 王新月

韩加怡, 张昀, 王新月. RP-HPLC梯度洗脱法测定泮托拉唑钠的有关物质及含量[J]. 中国药科大学学报, 2009, 40(6): 531-534.
引用本文: 韩加怡, 张昀, 王新月. RP-HPLC梯度洗脱法测定泮托拉唑钠的有关物质及含量[J]. 中国药科大学学报, 2009, 40(6): 531-534.
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梯度洗脱法测定泮托拉唑钠的有关物质及含量

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

  • 摘要: 目的 : 建立泮托拉唑钠及制剂的有关物质及含量的测定方法。 方法 : 采用VP-ODS C18柱(250 mm×4.6 mm,5 μm);流动相以 0.01 mol/L磷酸氢二钾溶液(用磷酸调节pH至7.0)-乙腈,梯度洗脱,0→30 min(90∶10→60∶40),30→45 min(60∶40→15∶85);柱温为40 ℃,流速为1.0 mL/min,检测波长为289 nm。 结果 : 泮托拉唑钠与各中间体及降解产物均良好分离,泮托拉唑钠在6.96~48.72 μg/mL范围内与峰面积呈良好线性关系(r=0.999 9),最低检测限与最低定量限分别为8.51 ng与17.0 ng。 结论 : 本方法能有效控制泮托拉唑钠有关物质,并可用于含量测定。
    Abstract: 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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  • 刊出日期:  2009-12-24

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