RP-HPLC法测定盐酸雷洛昔芬的含量Assay of Raloxifen Hydrochloride with RP-HPLC
陈燕忠,吕竹芬
CHEN Yan zhong; LU Zhu feng Guangdong College of Pharmacy, Guangzhou 510240
摘要(Abstract)：
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.
关键词(KeyWords)：
盐酸雷洛昔芬;高效液相色谱法;非水滴定法
raloxifen hydrochloride;HPLC;nonaqueous titrimetry
基金项目(Foundation): 广东省重点科技项目(编号2002C30107);; 广州市重点引导项目(编号:2003Z3-E4011)
作者(Authors):
陈燕忠,吕竹芬
CHEN Yan zhong; LU Zhu feng Guangdong College of Pharmacy, Guangzhou 510240
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