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目的采用HPLC法测定ET-26盐酸盐中的有关物质。方法采用Welch Xtimate C18色谱柱(250 mm×4.6 mm,5μm),流动相A为0.5%碳酸铵溶液,流动相B为乙腈,梯度洗脱,流速1.5 m L·min-1,柱温30℃,检测波长240 nm,进样量10μL。结果在选定的色谱条件下,主成分峰与各杂质峰完全分离,且各杂质峰的分离度良好;ET-26盐酸盐、依托咪酯酸和依托咪酯的线性范围均为0.5~20μg·m L~(-1),检测限分别为0.5、0.4、0.6 ng,定量限分别为1.6、1.3、1.8 ng。结论所用方法专属性强、灵敏度高,可用于ET-26盐酸盐中有关物质的检查。
Objective To determine the related substances in ET-26 hydrochloride by HPLC. The method was based on a Welch Xtimate C18 column (250 mm × 4.6 mm, 5 μm). The mobile phase A was 0.5% ammonium carbonate solution and the mobile phase B was acetonitrile. The gradient elution was performed at a flow rate of 1.5 m L · min-1. , Detection wavelength 240 nm, injection volume 10μL. Results Under the selected chromatographic conditions, the main component peaks were completely separated from the impurity peaks, and the impurity peaks were well separated. The linear range of ET-26 hydrochloride, etomidate and etomidate were 0.5 ~ 20μg · m L -1, the detection limits were 0.5,0.4,0.6 ng, the limit of quantification were 1.6,1.3,1.8 ng. Conclusion The method used is specific and sensitive and can be used for the examination of related substances in ET-26 hydrochloride.