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目的 建立多维软咀嚼片中维生素C含量测定及稳定性指示分析方法。方法 采用反相高效液相色谱法。色谱柱 :HypersilC1 8柱 (2 5 0mm× 4 .6mm) ;流动相 :0 .0 0 5mol·L-1 磷酸二氢钾溶液 (用磷酸调pH至 3.6 ) ;流速 :1 .0ml/min ;柱温 :2 5℃ ;检测波长 :2 4 6nm。结果 维生素C在 4 .1 8～ 836 .0 μg·ml-1 范围内呈良好线性 ,r =0 .9999(n =6 ) ,日内精密度小于 1 .0 % (n =5 ) ,平均回收率为 (1 0 0 .3± 1 .6 ) % ,最低检测限为 2 0ng。结论 本方法灵敏、准确、重现性好、操作简单 ,可作为多维软咀嚼片中维生素C含量测定及稳定性指示分析方法 ,以控制药物质量
Objective To establish a multi-dimensional soft chewable tablets vitamin C content determination and stability analysis. Methods Using reversed-phase high performance liquid chromatography. Column: HypersilC18 column (250 mm × 4 .6 mm); mobile phase: 0.050 mol·L -1 potassium dihydrogen phosphate solution (adjusted to pH 3.6 with phosphoric acid); flow rate: 1.0 ml / min; Column temperature: 25 ℃; detection wavelength: 246nm. Results Vitamin C showed a good linearity in the range of 4.18 ~ 836.0 μg · ml-1, r = 0.9999 (n = 6), and the intra-day precision was less than 1.0% (n = 5) The rate was (100 ± 0.3 ± 1.6)%, the lowest detection limit was 20 ng. Conclusion The method is sensitive, accurate, reproducible and easy to operate. It can be used as a method for the determination of vitamin C content and indication of stability in multidimensional soft chewable tablets to control the quality of drugs