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目的:建立测定注射用羟喜树碱中羟喜树碱含量的方法。方法:采用高效液相色谱法,色谱系统为Diamonsil C18色谱柱,以甲醇-水(60∶40)为流动相,检测波长为266nm,流速1.0ml/min。结果:表明羟喜树碱在浓度0.02mg·ml-1～0.18mg·ml-1范围内与峰面积线性关系良好;回归方程为:A=68332.8+71193165.88C;相关系数为r=0.9999。回收率为99.85%,RSD%为0.4。结论:用本法测定注射用羟喜树碱中羟喜树碱的含量,不仅保证羟喜树碱注射液中有效成分羟喜树碱的药效,而且操作快速简便,回收率良好。
Objective: To establish a method for determination of hydroxycamptothecin in injection of hydroxycamptothecin. Methods: The HPLC system was Diamonsil C18 with methanol-water (60:40) as the mobile phase at a detection wavelength of 266 nm and a flow rate of 1.0 ml / min. The results showed that hydroxycamptothecin had a good linear relationship with the peak area in the range of 0.02 mg · ml-1 ~ 0.18 mg · ml-1. The regression equation was: A = 68332.8 + 71193165.88C; correlation coefficient was 0.9999. The recovery was 99.85% with a RSD% of 0.4. Conclusion: The method of this method for the determination of hydroxycamptothecin for injection of hydroxycamptothecin content, not only to ensure that the effective component of hydroxycamptothecine injection of camptothecin in the efficacy, and the operation is quick and easy, good recovery.