高效液相色谱法测定多索茶碱注射液有关物质与含量

HPLC analysis of doxofylline for injection and its related substances

目的 对多索茶碱注射液的有关物质和含量进行方法学验证.方法 采用HPLC法测定多索茶碱注射液有关物质及含量.色谱条件：ODS填料（5 μm,150 mm×4.6 mm;Amethyst C18 H / Shimpack VP-ODS 已适用）,流动相：乙腈-磷酸盐缓冲液（18：82）,UV检测器（检测波长273 nm）;流速：1.0 mL·min-1;定量环：20 μL;运行时间：3倍主峰保留时间.结果 多索茶碱注射液有关物质杂质峰与主峰分离状况良好.在HPLC色谱中检测出多索茶碱含量在20.42～81.69 mg·L-1的浓度范围内线性关系良好,回归方程为A=41 928.608C＋17 709.760 （r=0.999 94,n=7）重复性、回收率、中间精密度良好,RSD均小于1%,该色谱系统稳定,溶液在24 h内稳定性良好.结论 所建立的方法快速正确,重现性好,专属性强.

Objective verification methodology of related substances and content of doxofylline injection. Method determining related substances and its content of doxofylline injection by using HPLC method. Chromatographic conditions ODS packing（5 μm, 150 mm × 4.6 ram;Amethyst C ls H/Shimpack VP-ODC has been available ）, mobile phase acetonitrile-phosphate buffer solution（ 18： 82）, the UV detector （detection wavelength 273 nm） ;flow rate 1.0 mL · min-1; quantitative ring 20 μL operating time 3 times the peak retention time. Results the separation condition of impurity peak and main peak is well. The amount of doxofylline detected by HPLC method in calibration range 20.42 - 81.69 mg · L-1 shows a good linear relationship and the regression equation is A =41 928. 608C ＋ 17 709. 760 （ r = 0. 999 94, n = 7 ）. Repeatability, recovery rate, intermediate precision are all good and RSD is always less than 1%. The chromato- graphic system is reliable and the solution remains stable in 24 hours. Conclusions the established method is fast, accurate and has good duplicability as well as strong specificity.