摘要
目的:建立高效液相法测定注射用匹多莫德中匹多莫德含量的方法。方法:采用Diamonsil-C18(4.6mm×250mm,5μm)色谱柱;流动相:0.01mol/LNaH2PO4-甲醇-水(97∶2∶1)(磷酸调节pH至pH=2.5);检测波长:210nm;流速:1.0ml/min。结果:匹多莫德在0.2732～4.3712μg范围内与峰面积呈良好的线性关系(r=0.9997),平均回收率为99.66%,RSD=0.80%(n=6)。结论:本方法简便、准确、重现性好,可用于注射用匹多莫德中匹多莫德的质量控制。
Objective：To establish a method for the content determination of pidotimod in Pidotimod for Injection by HPLC. Methods：The Diamonsil-C18 （4.6 mm×250 mm,5 μm） column was used. The mobile phases consisted of 0.01 mol/L-sodium dihydrogen phosphate dihydrate,methanol and water （97∶2∶1） （adjust pH to pH=2.5 by phosphoric acid）,the flow rate was 1.0 ml/min and the detection wavelength was at 210 nm. Results：The linear ranges of pidotimod was at 0.273 2-4.371 2 μg （r=0.999 7）,the average recovery was 99.66% with a RSD of 0.80% （n=6）. Conclusion：The method is fast,reliable,accurate and can be used in the quality control of pidotimod in Pidotimod for Injection.
出处
《中国医药导报》
CAS
2010年第10期88-89,共2页
China Medical Herald
