HPLC法测定氨茶碱氯化钠注射液中无水茶碱的含量

Detection the anhydrous theophylline concentration on aminophylline and sodium chloride injection fluid by HPLC

目的采用HPLC法测定氨茶碱氯化钠注射液中无水茶碱的含量。方法 Waters C18,流动相:乙腈-体积分数为0.1%磷酸水溶液(20∶80),流速为1.0mL/min,检测波长275nm。结果线性范围5.1～40.9mg/L,r=0.999 9,平均回收率99.06%(n=6),RSD=0.28%(n=6)。结论本法操作简便、方法准确、重现性好,可用于氨茶碱氯化钠注射液的质量控制。

Objective The method for detection of anhydrous theophylline concentration in injection fluid of Aminophylline and Sodium Chloride by HPLC was established.Methods Using Waters C18 column as column acetonitrile,-0.1% Phosphoric acid aqueous solution（20∶80） as the mobile phase,the detection flow rate was 1.0 mL/min,and the detection wavelength was 275 nm.Results The standard curve was linear relation at the range of 5.1-40.9 mg/L,r=0.999 9.The average recovery was 99.06%（n=6）,and the RSD was 0.28%（n=6）.Conclusion This method is simple,accurate,and good repeative.It can be used in the quality control of Aminophylline and Sodium Chloride injection fluid.