摘要
目的建立以反相高效液相色谱法测定吗替麦考酚酯胶囊含量的方法。方法色谱柱为ZorbaxEclipseXDB-C8柱(150mm×4.6mm,5μm),流动相为三乙胺磷酸缓冲液(pH=5.3)-乙腈(65∶35),柱温45℃,流速1.5mL/min,检测波长为250nm。结果吗替麦考酚酯质量浓度范围是0.0621～0.6211mg/mL(r=0.9998),平均回收率为100.08%,RSD=0.51%(n=9)。结论该方法准确、简便、快速、可靠,能有效控制吗替麦考酚酯胶囊的质量。
Objective To establish a HPLC method for detecting the content of Mycophenolate Mofetil Capsules. Methods The Zorbax Eclipse XDB-C8 column （150mm ×4.6 mm, 5 μm） was used,and the mobile phase was triethylamine phosphate buffer solution （pH = 5.3）- acetonitrile （65 ： 35）, the column temperature was 45 ℃ with the flow rate of 1.5 mL/min and the detection wavelength of 250 nm. Results The linear range of mycophenolate mofetil was 0. 062 1 -0. 621 1 mg/mL（ r =0. 999 8）. The average recovery rate was 100.08%, RSD = 0. 51% （n = 9）. Conclusion The method is accurate, simple, rapid and suitable for the quality control of Mycophenolate Mofetil Capsules.
出处
《中国药业》
CAS
2009年第1期27-28,共2页
China Pharmaceuticals
