高效液相色谱法测定盐酸瑞伐拉赞片的含量及有关物质

RP-HPLC determination of revaprazan hydrochloride content and related substance in its tables

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,5μm）色谱柱,以0.01 mol·L^-1醋酸铵（醋酸调p H为5.0）-乙腈（40∶60）为流动相,流速1.0 m L·min^-1,检测波长266 nm,柱温35℃,进样量20μL。结果：盐酸瑞伐拉赞质量浓度在0.010~0.100 mg·m L^-1范围内线性相关系数为0.999 6,最低检出限为0.1μg·m L^-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^-1ammonium acetate solution（ adjusted to p H 5. 0 with acetic acid） and acetonitrile（ 40∶ 60） at the flow rate of 1. 0 m L·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·m L^-1,the LOD was 0. 1 μg·m L^-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.