HPLC法测定注射用吗替麦考酚酯的含量

目的：建立注射用吗替麦考酚酯的含量测定方法。方法：色谱柱为Agilent C8（150×4．6mm，5μm）；流动相为乙腈-水-磷酸缓冲液（取三乙胺10ml，加水990ml，加磷酸调节至pH5．4）（35：45：20）；检测波长为249nm；流速为1．0ml·min^-1；柱温为45℃。结果：吗替麦考酚酯的线性范围为100—1000μg·ml^-1，r=0．9999。平均回收率为101．0％（RSD=1．4％）。结论：方法简便，结果准确，可用于该制剂的含量测定。

Determination the Content of Mycophenolate Mofetil for Injection by HPLC

Objective： To establish a HPLC method for the determination the content of mycophenolate mofetil for Injection. Method： The Agilent C8 （ 150mm × 4.6 mm, 5 μm） was used. the mobile phase consisted of acetonitrile-water-phosphonic acid buffer solution（ Takes triethylamine 10 ml, add water to 990 ml, then adjusted pH to 5.4 with phosphoric acid） （35： 45： 20）. the detection wavelength was 249 nm,the flow rate was 1.0 ml·min^-1 Result： The liner range of mycophenolate mofetil was 100 - 1000μg·ml^-1（ r = 0.999 9）. The average recovery was 101.0% （RSD = 1.4% ）. Conclusion： The method is simple, sensitive and accurate, It can be used for the quality control of mycophenolate mofetil for Injection.