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目的建立以反相高效液相色谱法测定注射用磷酸氟达拉滨中磷酸氟达拉滨含量的方法。方法色谱柱为AgilnetXDB-C18(150mm×4.6mm,5μm),流动相为0.008mol/L磷酸二氢钾溶液:乙腈=95:5,流速为1.0=ml/min,柱温为30℃,检测波长为261nm。结果磷酸氟达拉滨浓度在5～100μg/ml范围内与峰面积积分值呈良好线性关系(r=0.9997);平均回收率为99.6%,RSD=0.3%(n=9)。结论本方法操作简便,测定结果准确、重现性好,可用于测定注射用磷酸氟达拉滨中磷酸氟达拉滨的含量。
Objective To establish a method for the determination of fludarabine phosphate in injection of fludarabine by reversed-phase high performance liquid chromatography. Methods The column was AgilnetXDB-C18 (150mm × 4.6mm, 5μm). The mobile phase was 0.008mol / L potassium dihydrogen phosphate solution: acetonitrile = 95: 5, the flow rate was 1.0 mL / min and the column temperature was 30 ℃. The wavelength is 261 nm. Results The concentration of fludarabine in the range of 5 ~ 100μg / ml showed a good linear relationship with the peak area integral value (r = 0.9997). The average recovery was 99.6% and RSD was 0.3% (n = 9). Conclusion The method is simple, accurate and reproducible. It can be used to determine the content of fludarabine phosphate in the injection of fludarabine.