盐酸西布曲明片的溶出度测定

Determination of dissolution of sibutramine hydrochloride tablets by HPLC

目的:建立盐酸西布曲明片溶出的测定方法。方法:用HPLC法测定盐酸西布曲明片的溶出度。色谱柱为Shimadzu VP-ODS柱,流动相为甲醇-0.05mol/L KH2PO4(用磷酸调pH至3.0)(70:30),流速1.0mL/min,检测波长为223nm,线性范围为5.0-50.0μg/mL,平均回收率为100.6％,RSD为0.94％。结论:该方法线性关系良好、回收率高,可以用来控制盐酸西布曲明中的质量。

OBJECTIVE: Dissolution of sibutramine hydrochloride tablet was determinated by HPLC. The chromatography conditions were as follows: Column, Shimadzu VP - ODS; mobile phase: methol - 0. 05mol/L KH2PO4( adjusted to pH 3. 0 with H3PO4) (70 : 30) ; velocity of flow: 1mL/min; detection wavelength: 223nm. The linear ranges were 5. 0 -50. 0μg/mL. The average recoveries were 100. 6%.