HPLC测定吗替麦考酚酯的含量及有关物质

 目的建立测定吗替麦考酚酯含量及有关物质的高效液相色谱方法。方法采用AgilentXDB-C₈色谱柱(4.6mm×150mm,5μm),流动相为乙腈-0.1%三氟醋酸溶液(三乙胺调节pH至3.9)(35∶65),流速:1.0mL·min^-1。检测波长:250nm。结果各中间体及各降解产物均可与吗替麦考酚酯主峰良好分离。HPLC测定的线性范围为4.9～157.2mg·L^-1,r=0.9999;方法的日内与日间精密度RSD分别为0.65%和1.02%。结论采用HPLC测定吗替麦考酚酯的含量及有关物质,方法简便,结果准确可靠。

Determination of Mycophenolate Mofetil and Its Related Substances by HPLC

OBJECTIVE To develop a HPLC method for the determination of mycophenolate mofetil and its related substances.METHODS The separation was performed on an Agilent XDB-C₈ column(4.6 mm×150 mm,5 μm),and the mobile phase consisted of acetonitrile and 0.1% trifluoroacetic acid solution(adjusted to pH 3.9 with triethylamine)(35∶65)at the flow rate of 1.0 mL·min^-1.The detection was carried out at 250 nm.RESULTS An excellent separation was achieved for mycophenolate mofetil and its related substances.The method was validated in the concentration range of 4.9～157.2 mg·L^-1(r=0.999 9).The RSDs of intraday and interday precision were 0.65% and 1.02%.CONCLUSION The method developed is successfully used to determine mycophenolate mofetil and its related substances.