盐酸西布曲明片的溶出度测定
Determination of dissolution of sibutramine hydrochloride tablets by HPLC
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摘要: 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。Abstract: 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 H3P04)(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%.
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Key words:
- sibutramine hydrochloride /
- dissolution
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