HPLC法测定吗替麦考酚酯有关物质优化条件评定研究

Study on the selection of optimum condition for determination of mycophenolate mofetil by HPLC

目的建立以高效液相色谱法（HPLC）测定吗替麦考酚酯有关物质的各优化条件。方法采用AgilentC8色谱柱（4．6mm×150mm，5μm）。流动相采用乙腈一磷酸三乙胺缓冲液，用三乙胺调节pH值至3．8考评测试的麦考酚酯有关物质各种优化条件。结果HPLC法测定吗替麦考酚酸，测定波长250nm，线性范围为0．00831-0．0249μg·ml^-1，r=0．9996，本方法重复性和精密度良好。结论采用HPLC法测定吗替麦考酚酯有关物质，方法简便，结果准确。

Objective To establish high performance liquid chromatography （HPLC） method for determination of relevant compound to mycophenolatc mofctil. Methods Agilent C8 column（4,6mm×150mm,5μm） was used and acetonitrile and water （phosphoric acid-trithylaminc） in the ratios of 40：60 as mobile phase. The flow rate was 1ml·min^-1. The detection wavelength was 250nm, Results There was a good linear relationship within the range of 0.00831- 0. 0249μg·ml^-1 （ r = 0.9996）, The repruducibility and precision of the method was excellent. Conclusion The HPLC method is simple and accurate in determination of the compound relevant to mycophenolate mofctil.