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目的:建立反相高效液相色谱法测定阿坎酸钙含量的方法。方法:采用C_(18)色谱柱(250mm×4.6mm,5μm),以0.01mol·L~(-1)醋酸铵溶液(醋酸调pH为5)-甲醇(95:5)为流动相,流速0.5ml·min~(-1),检测波长220nm。结果:阿坎酸钙在1.5～10.0mg·ml~(-1)浓度范围内线性关系良好(r=0.9995),平均回收率为99.3%,RSD=1.O%(n=9),最低检测限为14ng。结论:方法准确,重复性好,可有效的控制阿坎酸钙原料药的质量。
Objective: To establish a method for the determination of acamprosate calcium by reversed-phase high performance liquid chromatography. Methods: The mobile phase consisted of C_ (18) column (250 mm × 4.6 mm, 5 μm), 0.01 mol·L -1 ammonium acetate solution (adjusted to pH 5 with acetic acid) and methanol 0.5ml · min ~ (-1), detection wavelength of 220nm. Results: Calcium aconitine had a good linear relationship (r = 0.9995) with the average recovery of 99.3% and RSD = 1.O% (n = 9) in the range of 1.5-10.0 mg · ml -1 The detection limit is 14ng. Conclusion: The method is accurate, reproducible and can effectively control the quality of acamprosate calcium drug substance.