反相高效液相色谱法测定地塞米松中有关物质

Determination of dexamethasone by RP-HPLC

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。

Object: To establish an HPLC method for the determination of dexamethasone. Methods: The HPLC separation was performed on a phenl column (4.6 mm×250 mm, 5 μm). The mobile phase consisted of acetonitrile-0.02 mol/Lammonium formate (pH 3.6, 22∶78, v/v). The flow rate was 1.0 ml/min, the temperature was kept at 40 oCand the detection wavelength was set at 254 nm. Results: There was a good linearity over the range of 5.04～151.2 μg/ml (r=0 999 99). The standard curve was Y=15.492 X-0.996 7. Conclusion: The established method was simple, rapid and accurate. It can be used for the quality control of dexamethasone.