高效液相色谱法测定注射用环磷酰胺的有关物质和降解产物

Determination of cyclophosphamide for injection and its related substances by HPLC

目的采用高效液相色谱法测定注射用环磷酰胺的有关物质和降解产物。方法使用C18色谱柱(150mm×4.6 mm,5μm),以水-乙腈(65∶35)为流动相,流速为1.0 mL/mim;检测波长为195 nm。结果主峰和各杂质峰均达到基线分离,理论板数按环磷酰胺峰计算不低于2 000。环磷酰胺的峰面积与浓度线性关系良好,r=0.999 9(n=5)。结论经方法学验证,该法灵敏、准确,适用于注射用环磷酰胺的有关物质的测定。

Purpose A high performance liquid chromatography method was established to determine the related substances and the degradation substances of cyclophosphamide. Methods The ODS column（ 150 mm ×4.6 mm,5 μm）was used, and water-acetonitrile（65：35）was used as the mobile phase. The flowing rate was 1.0 mL/mim. Detective wavelength was 195 nm. Results Main peak and individual impurity peak were separated well. The theoretical plate number of cyclophosphamide was not below 2 000. Conclusion The method has proved to be sensitive and accurate. It＇s quite suitable to be used in the analysis of related substances of cyclophosphamide.