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
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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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Keywords:
- pantoprazole sodium /
- related substances /
- determination /
- RP-HPLC /
- gradient elution
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