RP-HPLC法测定盐酸雷洛昔芬的含量

Assay of Raloxifen Hydrochloride with RP-HPLC

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 C_(18)(150×3.9mm,4μm),流动相为乙腈:0.05mol/L醋酸铵缓冲液(pH4.0±0.1)(43:57),流速1.0 ml/min,检测波长为289nm,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。

Objective To establish assaying methods for raloxifen hydrochloride with RP-HPLC. Methods With the column of No- va-Pak C_(18)(150×3.9mm,4mm), mobile phase of acetonitrile: 0.05 M ammonium acetate (pH4.0±0.1)(43:57), flow rate of 1. 0 ml/min, and detection wavelength of 289 nm,external standard method vas used and the assaying result of the sample was com- pared with that assayed with nonaqueous titrimetry.Reults In the concent ation range of 5～50 μg/ml, the distribution of raloxifen hydrochloride is linear (r=0.9999), with an average recovery of 100.35±0.15% (n=9). The assaying result of the samples is ap- proximately in accordance with that assayed with nonaqueous titrimetry. Conclusions The assaying method of KP-HPLC is conven- ient, accurate, and reliable with good precision, and can be used in the quality control of raloxifen hydrochloride.