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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 a RP-HPLC method for the determination of revaprazan hydrochloride tablets and related substances. Methods: The mobile phase consisted of 1.0 mol·L-1 ammonium acetate (acetic acid p H = 5.0) -acetonitrile (40:60) using Inertsil ODS-SP C18 (4.6 mm × 150 mm, 5 μm) m L · min-1, detection wavelength 266 nm, column temperature 35 ℃, injection volume 20μL. Results: The linear regression analysis showed that the linear regression coefficient (RSD) was within the range of 0.010 ~ 0.100 mg · m L-1 and the minimum detectable limit was 0.1 μg · m L-1 ) Was 99.3% (RSD = 0.73%). RSD of repeatability test was 0.1% (n = 6), RSD was less than 0.5% in 12 h stability test. There was a good resolution between Rehvassan peak and adjacent peaks . Conclusion: This method is validated by methodology and can be used for the quality control and related substance determination of revaprazan hydrochloride tablets.