目的 采用梯度HPLC法測(cè)定注射用硝酸異山梨酯的有關(guān)物質(zhì)。方法 采用Agela Venusil MP C₁₈（250 mm×4.6 mm，5 μm）色譜柱，以水-甲醇為流動(dòng)相，梯度洗脫，體積流量1.0 mL/min，檢測(cè)波長為210 nm，柱溫30℃。結(jié)果 系統(tǒng)適用性試驗(yàn)2-單硝酸異山梨酯峰與單硝酸異山梨酯峰分離良好，樣品中各雜質(zhì)及主峰的分離度和檢測(cè)靈敏度均能滿足有關(guān)物質(zhì)的測(cè)定要求。結(jié)論 本方法可用于測(cè)定注射用硝酸異山梨酯的有關(guān)物質(zhì)，為該品種的質(zhì)量評(píng)價(jià)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.