摘要
目的建立HPLC法测定麦考酚钠的含量及有关物质。方法采用Apllo C_(18)色谱柱(4.6 mm×250mm,5μm),以0.2%三乙胺溶液(用磷酸调p H至5.3)-乙腈(65∶35)为流动相,流速1.0 mL·min^(-1),检测波长250 nm,柱温35℃。结果麦考酚钠检出限为2.0 ng,在0.01~2.0 mg·mL^(-1)与峰面积呈良好的线性关系,相关系数r=0.9999(n=6),平均回收率均>98.0%,RSD均≤0.77%(n=3)。结论该方法操作简单,重复性好,检测结果准确,能很好地测定麦考酚钠的含量及有关物质。
Objective To establish a method to determine mycophenolate sodium and its related substances by HPLC. Methods HPLC was performed on an Apllo C18 （4.6 mm×250 mm, 5 μm） column. The mobile phase consisted of 0.2% triethylamine solution （ adjusted pH to 5.3 by phosphate） and acetonitrile （65 ： 35）. The flow rate was 1.0 mL·min^-1. The detection wavelength was 250 nm. The column temperature was 35℃. Results The limit of detection of mycophenolate sodium was 2.0 ng, and good linear relationship were obtained at 0.01 - 2.0 mg · mL^-1, r = 0.9999 （n = 6）. The average recovery was higher than 98.0% RSD ≤ 0.77% （n = 3）. Conclusion The method is simple, repeatable, accurate, and can be used to determine mycophenolate sodium and its related substances.
出处
《中南药学》
CAS
2018年第2期225-228,共4页
Central South Pharmacy
