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目的建立HPLC法测定醋酸泼尼松片及醋酸地塞米松片的有关物质。方法用C18柱,以乙腈-水(40 60)为流动相;检测波长为240nm。采用不加校正因子的自身对照法测定有关物质。结果线性范围:浓度分别为0.0523-0.157μg/ml,r=0.9999;0.4948-1.4772μg/ml,r=0.9999。最低检测限3ng,有关物质各杂质峰与主峰之间的分离度良好。结论本方法准确、简便、专属性强,可用于醋酸泼尼松片及醋酸地塞米松片的药品质量控制。
Objective To establish a HPLC method for the determination of prednisone acetate tablets and dexamethasone acetate tablets related substances. Methods C18 column with acetonitrile-water (40 60) as the mobile phase; detection wavelength of 240nm. Relevant substances were determined by self-control method without correction factor. Results The linear range: concentrations were 0.0523-0.157 μg / ml, r = 0.9999; 0.4948-1.4772 μg / ml, r = 0.9999, respectively. The minimum detection limit of 3ng, the impurities of various impurities and the peak separation between the good. Conclusion The method is accurate, simple and specific and can be used for the quality control of prednisone acetate tablets and dexamethasone acetate tablets.