HPLC测定盐酸特拉唑嗪胶囊含量及有关物质

Determination of content and related substances in terazosin hydrochloride capsule by HPLC

目的建立HPLC测定盐酸特拉唑嗪胶囊含量及有关物质的方法。方法 HPLC测定盐酸特拉唑嗪胶囊含量及有关物质。流动相为甲醇∶水∶冰醋酸∶三乙胺(330∶670∶10∶0.3);检测波长为245nm;色谱柱:Diamonsil(钻石)C18(150×4.6mm,5μm);柱温为室温;流速为1.0ml/min;灵敏度为0.05。结果制剂中其他成分不干扰测定,杂质峰和主峰达到有效分离。盐酸特拉唑嗪在4.34-13.03μg/ml浓度范围内与其峰面积呈良好的线性关系(r=0.9999,n=5)。结论 HPLC适用于测定盐酸特拉唑嗪胶囊含量及其有关物质,方法简单,结果准确,专属性强。

Objective To establish a HPLC method for determining the content and the related substances in terazosin hydrochloride capsule. Methods The analysis was conducted with a Dimonsil C18 column at room temperature,with methanol-water-glacial acetic acid-triethylamine solution（330：670：10：0.3） as the mobile phase,the detection wavelength at 246 nm,and the flow rate of 1 ml/min. Results Terazosin hydrochloride capsule was thoroughly separated with its related substances.The calibrated linear curve of terazosin hydrochloride was in the range of 4.34-13.03 μg/ml （r=0.999 9,n=5）. Conclusion The method is accurate and reliable. It could be used for the analysis of the content and related substances in terazosin hydrochloride capsule.