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建立高效液相色谱法测定琥珀酸去甲文拉法辛缓释片中去甲文拉法辛含量。采用Inertsil ODS-3 C18色谱柱(150 mm×4.6 mm,5μm),流动相为磷酸二氢钾缓冲液(取4.86g磷酸二氢钾,用水溶解并稀释至1000m L,加10m L三乙胺,用磷酸调节pH值至3.0±0.05)-乙腈(830∶170),柱温为30℃,流速为1.0 m L·min~(-1),检测波长为225 nm。去甲文拉法辛在40.57~60.85μg·m L~(-1)范围内与峰面积呈良好的线性关系(r=0.9991),低、中、高浓度平均回收率分别为99.85%、99.81%、99.83%,RSD分别为0.52%、0.24%、0.27%(n=3),检出限为0.25ng,日内、日间精密度RSD分别为0.43%和0.56%(n=6)。该方法灵敏、准确,专属性强,可作为琥珀酸去甲文拉法辛缓释片中的去甲文拉法辛含量测定方法。
To establish a method for the determination of desvenlafaxine in sustained-release desvenlafaxine succinate tablets by high performance liquid chromatography. Using Inertsil ODS-3 C18 column (150 mm × 4.6 mm, 5 μm), the mobile phase was potassium dihydrogen phosphate buffer (taking 4.86 g of potassium dihydrogen phosphate, dissolving in water and diluting to 1000 mL, adding 10 mL of triethylamine The pH of the solution was adjusted to 3.0 ± 0.05 with phosphoric acid to give acetonitrile (830:170). The column temperature was 30 ℃ and the flow rate was 1.0 m L · min -1. The detection wavelength was 225 nm. The desvenlafaxine showed a good linear relationship with the peak area (r = 0.9991) in the range of 40.57 ~ 60.85μg · m L -1, and the average recoveries of low, medium and high concentrations were 99.85% and 99.81 % And 99.83%, RSD were 0.52%, 0.24% and 0.27% respectively (n = 3). The detection limit was 0.25ng. The intra-day and interday RSD were 0.43% and 0.56%, respectively. The method is sensitive, accurate and specific and can be used as a method for determination of desvenlafaxine in desvenlafaxine succinate sustained-release tablets.