【摘要】 目的用高效液相色谱法测定盐酸西布曲明滴丸含量,为该滴丸的含量测定提供检测方法,制订质量控制标准。方法用十八烷基硅烷键合硅胶为填充剂,以磷酸二氢钾溶液(取磷酸二氢钾2.72 g,加水900 mL溶解,加三乙胺10 mL,用磷酸调节pH至3.0,加水稀释至1 000 mL)-甲醇(3∶7)为流动相,流速为1.0 mL/min,检测波长为223 nm。结果盐酸西布曲明质量浓度在10.0～499.0μg/mL范围内与峰面积线性关系良好,r=0.999 98。结论该法简便、准确、专属性好,可用于盐酸西布曲明滴丸的含量测定。更多还原

【Abstract】 Objective To determine the content of Sibutramine Hydrochloride Dripping Pills by the high performance liquid chromatography(HPLC) method,and to provide the detection method and the quality-control standards for the content determination of this preparation.Methods Octadecyl silane chemically bonded silica was adopted as the filling agent,with the mobile phase of the potassium dihydrogen phosphate solution(taking potassium dihydrogen phosphate 2.72 g,adding water 900 mL for dissolution and triethylamine 10 mL,adjusting pH to 3.0 by phosphoric acid,and then diluting to 1 000 mL with water)-methanol(3 ∶7).The flow rate was 1.0 mL/min and the detection wavelength was 223 nm.Results The concentration of sibutramine hydrochloride within the range of 10.0-499.0 μg/mL had good linear relationship,r=0.999 98.Conclusion This method has the advantages of convenience,accuracy and good specificity,which can be adopted for the content determination of Sibutramine Hydrochloride Dripping Pills.更多还原