采用有机硅聚合物包膜硅胶颗粒键合金刚烷基高效液相色谱柱检测舒更葡糖钠有关物质

A high performance liquid chromatography method for the determination of Sugammadex Sodium related substances by ADME column

目的建立一种简单、快速、准确分析舒更葡糖钠有关物质纯度的检测方法。方法针对于舒更葡糖钠及其游离酸合成过程中的副产物或降解杂质,采用有机硅聚合物包膜硅胶颗粒键合金刚烷基高效液相色谱柱(ADME),以0.025 mol/L磷酸二氢钠水溶液(用1.5 mol/L磷酸调节pH至3.0)∶乙腈=83∶20为流动相A,乙腈为流动相B,流速为0.27 mL/min,检测波长为200 nm,柱温为40℃,进样量为2.5μL。结果在该色谱条件下,舒更葡糖钠有关物质分离完全,线性良好,精密度良好,回收率在84.70%~119.99%。结论该方法灵敏度高,准确可靠,安全环保,可用于舒更葡糖钠有关物质纯度检测。

Objective Establish a simple,rapid,and accurate method for detecting the purity of substances related to Sugammadex Sodium.Methods Regarding the by-products or degradation impurities in the synthesis process of Sugammadex Sodium and its free acids,ADME(adamantane)bond alloy alkyl column was used with 0.025 mol/L sodium dihydrogen phosphate aqueous solution(pH adjusted to 3.0 with 1.5 mol/L phosphate)∶acetonitrile=83∶20 as mobile phase A and acetonitrile as mobile phase B.The flow rate was set at 0.27 mL/min,the detection wavelength was 200 nm,the column temperature was 40℃,and the sample size was 2.5μL.Results Under such chromatographic conditions,the separation of related substances of Sugammadex Sodium was complete,with good linearity and precision,and the recovery was within the range between 84.70%and 119.99%.Conclusion The method is sensitive,accurate,reliable,safe and environmentally friendly,which can be used to detect the purity of Sugammadex Sodium related substances.