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Agilent XDB-C色谱柱(4.6nm×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 sub-stances. METHODS Theseparation was perform ed on an Agilent XDB-C8 column（4.6nm×150mm,5μm）, and the mobilephase consisted of acetonitriie and 0.1% trifluoroacetic acid solution（adjusted to pH 3.9 with triethylamine）（35：65）at the flow rate of 1.0mL·min^-1. The detection was carried out at 250nm. RESULTS An excellent separation was achieved for mycophenolate mofetiland its related substances. The method was validated in the concentration range of 4.9--157.2mg· L^-1, （r= 0. 9999）. The RSDS of intraday and interday precision were 0.65% and 1.02% .CONCLUSION The method developed is successfully used to determinemycophenolate mofetil and its related substances.
出处
《海峡药学》
2010年第8期97-99,共3页
Strait Pharmaceutical Journal
