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目的采用HPLC法测定醋酸泼尼松片的有关物质。方法采用DIONEX Acclaim C18色谱柱(250 mm×4.6 mm,5μm),流动相为乙腈-水(42∶58),检测波长240 nm。结果泼尼松0.5～30μg.mL-1与峰面积呈良好线性关系(r=0.9999),最低检测限为0.25 ng;醋酸可的松0.5～30μg.mL-1与峰面积呈良好线性关系(r=0.9999),最低检测限为0.25 ng。结论所建方法准确、简便、快速,适用于醋酸泼尼松片的质量控制。
Objective To determine the related substances of prednisone acetate tablets by HPLC. Methods DIONEX Acclaim C18 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase was acetonitrile-water (42:58) and the detection wavelength was 240 nm. Results There was a good linearity (r = 0.9999) for prednisone at 0.5-30 μg.mL-1 and a peak detection limit of 0.25 ng. There was a good linear relationship between prednisone 0.5-30 μg.mL-1 and peak area (r = r = 0.9999) with the lowest detection limit of 0.25 ng. Conclusion The proposed method is accurate, simple and rapid and suitable for the quality control of prednisone acetate tablets.