HPLC法测定注射用地西他滨的含量

Determination of Decitabine for Injection by HPLC

目的建立测定注射用地西他滨含量的HPLC法。方法采用Kromasil C18柱(250mm×4.6mm,5μm);流动相为0.01mol.L-1 K2HPO4(用1mol.L-1 HCl调节pH值为6.0);流速为1mL.min-1;柱温为25℃±2℃;检测波长为220nm。结果地西他滨进样量在57.92～1 158.3ng范围内与峰面积呈良好的线性关系(r=0.999 8),平均加样回收率为100.0%(n=9),RSD为0.5%。结论该法操作简便、准确可靠,可作为注射用地西他滨含量测定的方法。

Objective To establish an HPLC method for the determination of Decitabine for Injection.Methods The test was carried out on a Kromasil C18 column（250 mm×4.6 mm,5 μm） with 0.01 mol·L-1 K2HPO4（pH value 6.0 adjusted by 1 mol·L-1 HCl） as the mobile phase,the flow rate was 1 mL·min-1,the column temperature was 25 ℃±2 ℃,and the detection wavelength was 220 nm.Results Within the range of 57.92-1 158.3 ng,there was a good linear correlation（r=0.999 8）.The average recovery was 100.0%（n=9）,and RSD was 0.5%.Conclusion The method is simple,accurate,and can be used for the determination of Decitabine for Injection.