摘要:目的建立测定盐酸雷洛昔芬含量的RP-HPLC方法.方法:色谱柱为Nova-Pak C18(150×3.9 mm,4 μm),流动相为乙腈:0.05 mol/L醋酸铵缓冲液(pH4.0±0.1)(43:57),流速1.0 ml/min,检测波长为289 nm,采用外标法,并将样品测定结果与非水滴定法进行比较.结果盐酸雷洛昔芬在5~50μg/ml浓度范围内呈良好的线性关系(r=0.9999),平均回收率(n=9)为(100.35±0.15)%;样品含量测定结果与非水滴定法基本一致.结论方法简便、准确、精密度好,可用于盐酸雷洛昔芬的质量控制.
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