HPLC法测定甲氧苄啶片主药及有关物质的含量

Content Determination of Trimethoprim and Its Related Substances by HPLC

目的:建立高效液相色谱法测定甲氧苄啶片中主药及有关物质的含量。方法:色谱柱为Waters symmetry C18,流动相为峰0.0能15有m效ol·分L离-1磷;甲酸(氧p苄H啶3.5检)-测乙浓腈度(8线3:性17范),围检为测波16长.1～为126711.3nμmg,·流m速L-为(1r1=.00m.9L9·9m9i,nn-=1,柱5)温;平为均30回℃收。率结为果1:0甲0.4氧%苄,R啶S与D=其0相.7%邻(杂n=质9);有关物质含量<0.6%。结论:该方法简便、准确,专属性强,可用于甲氧苄啶片的含量测定及有关物质的检查。

OBJECTIVE： To establish an HPLC method for determination of trimethoprim and its relative substance in Trimethoprim tablets. METHODS： Waters Symmetry C,8 Column was adopted with 0.015 mol·L^-1 phosphorous acid （pH 3.5）-acetonitrile （83： 17） as mobile phase at flow rate of 1.0 mL·min^-1. The detection wavelength was set at 271 nm and colunm temperature was 30℃. RESULTS ： Good separation between trimethoprim and main related substance was achieved. The linear range of trimethoprim were 16.1-161.3 μg·L^-1（r=0.999 9, n=5）. The average recovery was 100.4% （RSD=0.7%, n=9）. The content of related substance was lower than 0.6%. CONCLUSION： This method is simple, accurate and specific for content determination of Trimethoprim tablets and its related substances.