HPLC法测定多索茶碱注射液中的工艺杂质及降解产物

目的：建立多索茶碱注射液有关物质的测定方法。方法采用 Agilent TC-C18（4.6 mm×250 mm，5μm）色谱柱；流动相：乙腈-磷酸盐缓冲液（pH 5.0）（20：80）；柱温30℃；流速1.0 mL·min-1；检测波长274 nm。结果茶碱、杂质 B、杂质 D 在0.031~9.62、0.043~9.080、0.126~10.561μg·mL-1浓度范围内，线性关系良好，相关系数 r的数值不小于0.999；平均回收率分别为101.4％、99.3％、96.6％，RSD 分别为0.3％、0.9％、1.4％（n=9）。结论建立的方法灵敏度高，测定结果准确，可用于多索茶碱注射液中工艺杂质和降解产物的测定。

Determination of process impurities and degradation products in Doxofylline Injection by HPLC

Objective To establish an HPLC method for the determination of process impurities and degradation prod-ucts in Doxofylline Injection.Methods The assay was performed on an Agilent TC-C18 column(4.6 mm×250 mm,5 μm) with acetonitrile-phosphate buffer(pH 5.0)(20: 80)as mobile phase,the flow rate was 1.0 mL·min-1 ,the column tem-perature was 30 ℃ and the detection wavelength was 274 nm.Results Good linearity was obtained in 0.031~9.62,0.043~9.080 and 0.126~ 10.561 μg·mL-1 for theophylline,impurity B and inmpurity D,respectively.The correlation coefficient was at least 0.999.The average recovery rates of theophylline,impurity B and impurity D were 101.4%( RSD = 0.3%), 99.3%(RSD= 0.9%),96.6%(RSD= 1.4%),n= 9.Conclusion The method can be used for the determination of process impurities and degradation products in Doxofylline Injection with high sensitivity,accurate and reliable results.