摘要
目的建立盐酸丙卡巴肼胶囊的含量及其有关物质检查方法。方法应用高效液相色谱技术,色谱柱为Waters XBridge TM C8柱(250mm×4.6mm,5μm),以0.01mol·L^(-1)磷酸二氢钾溶液-乙腈-甲醇(85∶11∶4)为流动相,流速:1.0m L·min-1,检测波长为242nm。结果盐酸丙卡巴肼与已知杂质分离良好,盐酸丙卡巴肼在24.13μg·m L^(-1)~120.64μg·m L^(-1)浓度范围内呈良好线性关系(r=0.9999);平均回收率为99.3%(n=9),RSD为0.8%。盐酸丙卡巴肼的检出限为0.005%。结论本法简便、准确、重复性好,该方法可作为盐酸丙卡巴肼的含量测定及有关物质检查的方法。
OBJECTIVE To establish a HPLC method to determine the content and related substances of Pro- carbazine Hydrochloride Capsule. METHODS A Waters XBridgeTM Cs column （250mm×4. 6mm, 5μm）was used with the mobile phase of 0. 01 mol·L^-1 potassium dihydrogen phosphate acetonitrile-methol（85：11：4）. The detection wavelength was242nm. The flow velocity was 1.0mL·min^-1. RESULTS Procarbazine Hydrochloride and its related impurities could be separated effectively. The concentration-response relationship was linear over the range of 24. 13μg·mL^-1 - 120. 64μg·mL^-1 （ r = 0. 9999）. The average recovery was 99.3% （ RSD = 0. 8%, n = 9 ）. The detection limit of Procarbazine Hydrochloride is 0. 005 %. CONCLUSION The method is simple, accurate, good re- peatability and suitable for the determination of content and related substance of Procarbazine Hydrochloride.
出处
《海峡药学》
2017年第7期69-71,共3页
Strait Pharmaceutical Journal
