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目的采用HPLC法测定复方四环素泼尼松膜中醋酸泼尼松的含量。方法采用Diamonsil C18色谱柱(250 mm×4.6mm,5μm),甲醇-水(65∶35)为流动相,流速1.0 mL.mim-1,检测波长240 nm。结果 25～250μg·mL-1醋酸泼尼松与峰面积的线性关系良好(r=0.9999),平均回收率为95.06%,RSD=1.14%(n=9)。结论所用方法操作简单、重复性好、测定结果准确,可用于复方四环素泼尼松膜的质量控制。
Objective To determine the content of prednisone acetate in compound tetracycline prednisone film by HPLC. Methods Diamonsil C18 column (250 mm × 4.6 mm, 5 μm) and methanol-water (65:35) were used as the mobile phase at a flow rate of 1.0 mL.mim-1 with a detection wavelength of 240 nm. Results The linear relationship of prednisone with 25 ~ 250μg · mL-1 acetate peak area was good (r = 0.9999). The average recovery was 95.06%. The average RSD was 1.14% (n = 9). Conclusion The method is simple, reproducible and accurate. It can be used for the quality control of compound tetracycline prednisone film.