梯度洗脱HPLC法测定阿那曲唑及片中的有关物质

发布时间：2019-03-14 14:52

【摘要】：目的:建立梯度洗脱HPLC法测定阿那曲唑原料药及片中的有关物质。方法:采用Welch Ultimate C18色谱柱(4.6 mm×250 mm,5μm),流动相A为乙腈-水(40∶60),流动相B为乙腈-水(60∶40),线性梯度洗脱,流速1.0 m L·min-1,柱温35℃,检测波长215 nm。结果:阿那曲唑与6种中间体、副产物完全分离。各杂质的线性关系良好,平均回收率均在97%~113%之内,重复性RSD为5.1%,检测限为0.02~0.04μg·m L-1。有关物质测定结果:异构体为0~0.19%,杂质B为0~0.01%,杂质C为0~0.04%,杂质A为0~0.08%,杂质D为0~0.01%,杂质E为0~0.04%,其他单个最大杂质为0.05%~0.28%,杂质总量为0.06%~0.42%。结论:经方法学验证,本法可用于阿那曲唑及片剂中的杂质检测。
[Abstract]:Objective: To establish a gradient elution HPLC method for the determination of the drug substance and related substances in the drug substance and tablet. Method: Welch Ultimate C18 column (4.6 mm,250 mm,5. mu.m) was used. The mobile phase A was acetonitrile-water (40:60). The mobile phase B was acetonitrile-water (60:40), the linear gradient was eluted, the flow rate was 1.0 m L 路 min-1, the column temperature was 35 鈩，

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