HPLC测定复方四环素片4个组分的含量

Determination of Four Components of Compound Tetracycline Tablets by HPLC

目的建立HPLC同时测定复方四环素片中盐酸四环素、甲氧苄啶、维生素B1、维生素B6 4个组分含量测定的方法。方法采用Phenomenex C18（150 mm×4.6 mm,5μm）色谱柱,流动相为甲醇-0.05%庚烷磺酸钠溶液-三乙胺（用冰醋酸调pH至3.5）（20∶80∶0.3）,流速：1 mL.min-1,检测波长246 nm。结果盐酸四环素、甲氧苄啶、维生素B1、维生素B6的线性范围分别为20~160μg.mL-1,8~64μg.mL-1,1~8μg.mL-1,1~8μg.mL-1,r都为0.999 9,平均加样回收率分别为100.1%,100.3%,99.3%,100.5%。结论该方法简便、准确、重复性好,可用于同时测定复方四环素片中4个组分的含量。

OBJECTIVE To establish an HPLC method for the content determination of tetracycline hydrochloride,trimethoprim,vitamin B1 and vitamin B6 in compound tetracycline tablets.METHODS The Phenomenex Cl8（150 mm×4.6mm,5 μm） column was used,the mobile phase was methanol-0.05% sodium heptanesulfonate-triethylamine（pH=3.5 adjusted by acetic acid）（20∶80∶0.3）,the flow rate was 1 mL.min-1 and the detection wavelength was set at 246 nm.RESULTS The calibration curve linear of tetracycline hydrochloride,trimethoprim,vitamin B1 and vitamin B6 were 20-160 μg.mL-1（r=0.999 9）,8-64 μg.mL-1（r=0.999 9）,1-8 μg.mL-1（r=0.999 9）,1-8 μg.mL-1（r=0.999 9） respectively.The average recover were 100.1%,100.3%,99.3%,100.5%,respectively.CONCLUSION The method is simple,accurate,reproducible,and it can be used for the quality control of compound tetracycline tablets.