RP-HPLC法测定注射用磷酸氟达拉滨中磷酸氟达拉滨的含量

RP-HPLC method for the determination of fludarabine phosphate in fludarabine phosphate for injection

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 fludarabine phosphate for injection by RP-HPLC.Methods Chromatography was performed on Agilnet XDB-C18（150 mm × 4.6 mm,5 μm）.The mobile phase was 0.008 mol/L monobasic potassium phosphate solution-Acetonitrile（95 ﹕ 5）.The flow rate was 1.0 ml/min.Detective wavelength was 261 nm.Results The calibration curves of Fludarabine Phosphate is linear within the range of 5 ～ 100 μg/ml.The average recovery was 99.6% and RSD was 0.3%.Conclusion This method is easy to operate and has good accuracy and repeatability.It can be used for the quality control of Fludarabine Phosphate for injection.