HPLC测定甲氧依托咪酯原料药中的有关物质

Determination of related substances in Methoxyetomidate by HPLC

目的采用HPLC法测定新型咪唑类全麻药甲氧依托咪酯原料药中的有关物质。方法采用Waters X-Select C18色谱柱(250 mm×4.6 mm, 5μm),流动相A为pH2.0磷酸溶液,流动相B为甲醇和乙腈(5:100)的混合溶液,梯度洗脱。结果甲氧依托咪酯与8种有关物质可完全分离,分离度大于1.5,线性关系良好;最低检测限为0.08μg·mL-1。5批样品中各已知杂质的含量均低于0.20%,其他单个未知杂质均低于0.10%,杂质总含量低于1.00%。结论所用方法适用于甲氧依托咪酯原料药中有关物质的检测。

OBJECTIVE To determine related substances in Methoxyetomidate by HPLC.METHODS Waters X-Select C_(18)(250 mm×4.6 mm, 5 μm) column was used.The mobile phase A was pH2.0 phosphoric acid solution.The mobile phase B was a mixture of methanol and acetonitrile(5:100).Gradient elution was used.RESULTS Methoxyetomidate and 8 related substances could be completely separated, and the resolution was more than 1.5.The linear relationship was good, and the lowest detection limit was 0.08 μg·mL-1.The determination results of related substances in five batches of samples showed that the content of known impurities was less than 0.20% and the other single unknown impurities was less than 0.10%.The total content of impurities was less than 1.00%.CONCLUSION This method is suitable for the determination of related substances in Methoxyetomidate.