多索茶碱注射液中有关物质的HPLC法测定

Determination of Related Substances in Doxofylline Injection

改进多索茶碱注射液有关物质的HPLC分析方法.采用C18色谱柱,以乙腈∶水（10∶90）为流动相,检测波长273 nm.多索茶碱及其有关物质A和B在0.2～3μg/ml范围内线性关系良好;最低检测限分别为8.3、16.7和14.8 ng/ml.有关物质A和B的平均回收率为100.1％和102.1％,RSD为1.2％～2.7％.

The HPLC method was improved for the determination of the related substances in doxofylline injection. A C18 column was used, with the mobile phase of acetonitrile ： water （10 ： 90）, at the detection wavelength of 273 nm. The calibration curves for doxofylline and its related substances A and B were linear in the range of 0.2 - 3μg/ml. Their low limits of detection were 8.3, 16.7 and 14.8 ng/ml. The average recoveries of related substances A and B were 100. 1% and 102.1%, with RSDs of 1.2 % - 2.7 %.