RP-HPLC测定IDP α晶型的含量及其有关物质

RP-HPLC determination of content of IDP α polymorph and its related substances

目的：建立反相高效液相色谱法测定IDPα晶型的含量及其有关物质。方法：采用梯度洗脱（线性梯度）方法,色谱柱：Diamonsil C18（250mm×4.6mm,5μm）;流动相：流动相A为乙腈,B为水;检测波长为228nm;流速：1.2mL·min-1。结果：在该条件下,IDPα晶型主峰与有关物质得到了很好的分离;在10-80μg.mL-1范围内,浓度与相应的峰面积呈良好的线性关系（r=0.9999）;最低定量限和最低检测限分别为14ng和4ng。结论：本方法简便、准确,专属性好,可用于质量控制。

Objective：To establish an RP-HPLC method for the determination of IDP α polymorph and its related substances.Methods：The HPLC method was conducted on a Diamonsil C18 column（250 mm×4.6 mm,5 μm）and UV detector at 228 nm.The gradient elution was used with a flow rate of 1.2 mL·min-1.The mobile phase was acetonitrile（A）and water（B）.Results：Using this method,IDP α polymorph and its related substances were well separated.The linear ranges were 10-80 μg·mL-1（r=0.9999）;the limit of detection and the limit of quantification were 14 ng and 4 ng,respectively.Conclusion：The proposed method is simple,accurate and specific for the quality control of IDP α polymorph.