高效液相色谱法测定盐酸瑞伐拉赞片的含量及有关物质

目的: 建立RP-HPLC法测定盐酸瑞伐拉赞片的含量和有关物质。方法: 采用Inertsil ODS-SP C₁₈(4.6 mm×150 mm,5 μm)色谱柱,以0.01 mol·L^-1醋酸铵(醋酸调pH为5.0)-乙腈(40:60)为流动相,流速1.0 mL·min^-1,检测波长266 nm,柱温35℃,进样量20 μL。结果: 盐酸瑞伐拉赞质量浓度在0.010~0.100 mg·mL^-1范围内线性相关系数为0.999 6,最低检出限为0.1 μg·mL^-1,平均加样回收率(n=6)为99.3%(RSD＝0.73%),重复性试验RSD为 0.1%(n=6),12 h稳定性试验的RSD小于0.5%;瑞伐拉赞峰和相邻峰之间有良好的分离度。结论: 该法经方法学验证,可用于盐酸瑞伐拉赞片的质量控制及有关物质测定。

Objective: To establish an RP-HPLC method for the determination of revaprazan hydrochloride content and related substance in its tables. Methods: The Inertsil ODS-SP C₁₈(4.6 mm×150 mm,5 μm)column was adopted with a mobile phase consisting of 0.01 mol·L^-1 ammonium acetate solution(adjusted to pH 5.0 with acetic acid)and acetonitrile(40:60)at the flow rate of 1.0 mL·min^-1.The detection wavelength was 266 nm,the column temperature was controlled at 35℃,and the inject volume was 20 μL. Results: The correlation coefficient of revaprazan hydrochloride was 0.999 6 in the range of 0.010-0.100 mg·mL^-1,the LOD was 0.1 μg·mL^-1,and the average recovery was 99.3%(RSD=0.73 %,n=6).The RSD of the repeatability test was 0.1%(n=6),the RSD of the 12 h stability was below 0.5%;the satisfactory resolution between revaprazan peak and its adjacent peaks was achieved. Conclusion: The established method is proved to be applicable for quality control,and related substance determination of the revaprazan hydrochloride tablets.

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