摘要
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。
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% trifluoroaeetic 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.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2007年第10期780-782,共3页
Chinese Pharmaceutical Journal
