HPLC测定抽验盐酸特拉唑嗪口服制剂中的有关物质

Determination of the related compounds of Terazosin hydrochloride solid oral dosage forms by HPLC

目的用HPLC法测定盐酸特拉唑嗪口服固体制剂中的有关物质。方法采用Diamonsil C8色谱柱(250 mm×4.6mm,5μm),流动相为乙腈-柠檬酸盐缓冲液-三乙胺(17.5∶82.5∶0.1),流速1.0 mL·L-1,检测波长245 nm。结果在抽检的285批样品中,共检出4个已知杂质,8个未知杂质。结论所用方法简便、准确、重复性好,可作为盐酸特拉唑嗪口服固体制剂的质量控制方法。

OBJECTIVE To detect the related compounds of Terazosin hydrochloride solid oral dosage forms by HPLC. METHODS The analytical column was Diamonsil Cs column（250 mm × 4.6 mm ,5 μm）. The mobile phase was consisted of acetonitrile- citrate buffer - triethylamine（ 17.5 ： 82.5 ： 0.1 ）. The flow rate was 1.0 mL. L-1 and the detective wavelength was 245 nm. RESULTS For all 285 batches of sampling inspection, 4 known related compounds and 8 unknown related compounds were found. CONCLUSION The method is simple, accurate and reliable. It can be used for the quality control of Terazosin hydrochloride solid oral dosage forms.