高效液相色谱法测定色甘酸钠地塞米松滴鼻液含量

Determination of the Content of Dexamethasone Sodium Phosphate and Sodium Cromoglycate by HPLC

目的建立一种HPLC法同时测定地塞米松色甘酸钠滴鼻液中磷酸地塞米松和色甘酸钠含量.方法采用Diamonsil C18(150 mm×4.6 mm,5μm)色谱柱,流动相:A:缓冲液(0.01 mol/L磷酸二氢钾,pH为4.7),B:甲醇,0～5 min:A-B(42:58),6 min后A-B(30:70),流速:1 mL/min,柱温:25℃,检测波长:240 nm.外标法计算含量.结果在该色谱条件下,磷酸地塞米松和色甘酸钠线性良好(r＞0.999,n=6),加样回收率为98%～102.55%(n=3),RSD＜2.0%(n=3).样品在8 h内稳定.测得样品含量合格,在97%～103%.结论经方法学实验验证,该方法简便,快速,结果准确,可靠,重现性好.

Purpose To develop a high performance liquid chromatography to determine the content of dexamethasone sodium phosphate and sodium cromoglycate. Methods The HPLC separation was carried out on a Diamonsil C 18(150 mm×4.6 mm,5 μm) column,using a UV detector and the wavelength was 240 nm.The mobile phase was 10 mm Na2HPO4(pH 4.7)-CH3OH(42∶58,V/V)in the first 5 minutes.After 6 minutes the mobile phase was 10 mm Na2HPO4(pH 4.7)-CH3OH(30∶70,V/V).The temperature of the column was 25?℃. Results Two good linearity were demonstrated by linear equation (r>0.999, n=7).The samples were qualified. Conclusions The method was proved to be accurate, sensitive and reliable.