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目的 :建立反相高效液相色谱法测定地塞米松中有关物质的方法。方法 :采用 Hypersil BDSphenyl为固定相(4 .6 mm× 2 5 0 mm,5 μm) ,柱温 4 0 o C,以乙腈 - 0 .0 2 mol/ L 甲酸铵缓冲液 (用甲酸溶液调节溶液至 p H=3.6 ) (2 2 :78)为流动相 ,流速 1.0 ml/ min,检测波长 2 5 4 nm。结果 :地塞米松在 5 .0 4～ 15 1.2μg/ ml浓度范围内与峰面积呈良好线性关系 ,回归方程 :Y=15 .4 92 X - 0 .996 7,r=0 .9999。结论 :该方法专属性强 ,较薄层法简便、快速 ,结果准确 ,适用于地塞米松的质量控制。
Objective: To establish a method for the determination of related substances in dexamethasone by reversed-phase high performance liquid chromatography. Methods: Hypersil BDSphenyl was used as the stationary phase (4.6 mm × 250 mm, 5 μm). The column temperature was kept at 40 ° C and acetonitrile-0.02 mol / L ammonium formate buffer (adjusted with formic acid solution To p H = 3.6) (2 2: 78) as the mobile phase at a flow rate of 1.0 ml / min at a detection wavelength of 254 nm. Results: Dexamethasone showed a good linear relationship with the peak area in the concentration range of 0.54 ~ 15 1.2μg / ml. The regression equation was Y = 15.492 X - 0.996 7, r = 0.9999. Conclusion: The method is highly specific and the thin-layer method is simple, rapid and accurate. It is suitable for the quality control of dexamethasone.