改进HPLC法测定阿那曲唑原料药中的有关物质 点击下载
论文标题: 改进HPLC法测定阿那曲唑原料药中的有关物质
英文标题:
中文摘要: 目的:改进高效液相色谱法测定阿那曲唑原料药中的有关物质。方法:色谱柱为Welch Materials XB C18,改进后的流动相为乙腈-水(35 ∶ 65,V/V),流速为1.0 mL/min,检测波长为210 nm,柱温为25 ℃,进样量为20 μL。结果: 阿那曲唑原料药中仅检测出1个杂质(杂质A),检测质量浓度线性范围为0.1~1.6 μg/mL(r=0.999 6);定量限为0.1 μg/mL,检测限为0.02 μg/mL;精密度、稳定性、重复性试验的RSD<2.0%;加样回收率为98.95%~105.29%(RSD=1.78%,n=9)。结论:改进后的方法操作简便、结果准确,可用于测定阿那曲唑原料药中的有关物质。
英文摘要: OBJECTIVE: To establish a method for the determination of related substances in anastrozole. METHODS: HPLC was performed on the column of Welch Materials XB C18 with mobile phase of acetonitrile-water (35 ∶ 65,V/V) at a flow rate of 1.0 mL/min, detection wavelength was 210 nm, column temperature of 25 ℃, and the injection volume was 20 μL. RESULTS: Only one impurity (impurity A) was detected in anastrozole, the linear range was 0.1-1.6 μg/mL (r=0.999 6); limit of quantitation was 0.1 μg/mL, limit of detection was 0.02 μg/mL; RSDs of precision, stability and reproducibility tests were lower than 2%; recovery was 98.95%-105.29% (RSD%=1.78%,n=9). CONCLUSIONS: The method is simple, accurate, and can be used for the determination of related substances in anastrozole.
期刊: 2017年第28卷第9期
作者: 周丽云,胡婷霞,李宏,姚彤炜
英文作者: ZHOU Liyun,HU Tingxia,LI Hong,YAO Tongwei
关键字: 阿那曲唑原料药;有关物质;高效液相色谱法
KEYWORDS: Anastrozole; Related substance; HPLC
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