目的 采用梯度HPLC法测定注射用硝酸异山梨酯的有关物质。方法 采用Agela Venusil MP C₁₈（250 mm×4.6 mm，5 μm）色谱柱，以水-甲醇为流动相，梯度洗脱，体积流量1.0 mL/min，检测波长为210 nm，柱温30℃。结果 系统适用性试验2-单硝酸异山梨酯峰与单硝酸异山梨酯峰分离良好，样品中各杂质及主峰的分离度和检测灵敏度均能满足有关物质的测定要求。结论 本方法可用于测定注射用硝酸异山梨酯的有关物质，为该品种的质量评价提供更具分辨力的方法。

Objective To determinate the related substances in Isosorbide Dinitrate for Injection by HPLC. Methods The Agela Venusil MP C₁₈ column (250 mm×4.6 mm, 5 μm) was used as the analysis column, the mobile phase composed of a mixture of water and methanol with gradient elution at a flow rate of 1.0 mL/min, the detection wavelength was 210 nm, and the column temperature was 30℃. Results Under this condition, the resolutions between isosorbide mononitrate and isosorbide 2-nitrate could meet requirement. The sensitivity of the method was acceptable. Conclusion The method developed in the paper can provide an specific, efficient, and convenient method for quality control and evaluation of Isosorbide Dinitrate for Injection.