高效液相色谱法测定盐酸西布曲明滴丸的含量

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。

Content Determination of Sibutramine Hydrochloride Dripping Pills by HPLC

Objective To determine the content of Sibutramine Hydrochloride Dripping Pills by the high performance liquid chromatogra- phy （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 potas- sium dihydrogen phosphate solution （taking potassium dihydrogen phosphate 2.72 g, adding water 900 mL for dissolution and triethy- lamine 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.