改进HPLC法测定阿那曲唑原料药中的有关物质

发布时间：2018-12-24 11:26

【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 C_(18),改进后的流动相为乙腈-水(35∶65,V/V),流速为1.0 m L/min,检测波长为210 nm,柱温为25℃,进样量为20μL。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0.1~1.6μg/m L(r=0.999 6);定量限为0.1μg/m L,检测限为0.02μg/m L;精密度、稳定性、重复性试验的RSD2.0%;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。
[Abstract]:Objective: to improve the HPLC method for the determination of related substances in Anatrizole. Methods: the chromatographic column was Welch Materials XB C18, the improved mobile phase was acetonitrile-water (35: 65 V / V), the flow rate was 1.0 mL / min, the detection wavelength was 210 nm, the column temperature was 25 鈩，

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