HPLC法测定“肤炎膏”中马来酸氯苯那敏和地塞米松含量

Simultaneous Content Determination of Chlorpheniramin Maleate and Dexamethasone in Fuyan Ointment by HPLC

目的为提高＂肤炎膏＂的质量标准,建立同时测定＂肤炎膏＂中马来酸氯苯那敏和地塞米松含量的HPLC方法。方法采用RPHPLC法。色谱柱为DIKMA Diamonsil C18（250 mm×4.6 mm,5μm）柱,流动相为磷酸盐缓冲液（磷酸二氢铵11.5 g,加水适量使溶解,加磷酸1 m L,用水稀释至1 000 m L）-乙腈=62∶38,流速为1.0 m L/min,进样量为10μL,检测波长为240 nm。采用外标法计算含量。结果马来酸氯苯那敏检测浓度在5.28-52.8μg/m L范围内与峰面积积分值呈良好线性关系（r=0.999 9）,低、中、高浓度组平均加样回收率分别为100.41%、104.03%和103.66%,RSD为1.94%;地塞米松检测浓度在1.24-12.4μg/m L范围内与峰面积积分值呈良好线性关系（r=0.999 9）,低、中、高浓度组平均加样回收率分别为99.95%、104.70%和103.59%,RSD为2.42%。结论该方法简便、准确、重复性好,可用于＂肤炎膏＂的质量控制。

Objective To improve the quality standard of the Fuyan ointment,a simultaneous content determination method of chlorpheniramin maleate and dexamethasone in Fuyan ointment by HPLC was established. Methods RP-HPLC method was adopted. The column was DIKMA Diamonsil C18（ 250 mm×4. 6 mm,5 μm） column,the mobile phase was composed of phosphate buffer（ dissolve 11. 5 g ammonium dihydrogen phosphate and 1 m L phosphate in 1 000 m L water）-acetonitrile（ 62 ∶38） at a flow rate of 1. 0 m L/min,the injection was 10 μL,and the detection wavelength was 240 nm. The content of chlorpheniramin maleate and dexamethasone was determined by external standard method. Results The linear range of chlorpheniramin maleate was 5. 28-52. 8 μg / m L（ r = 0. 999 9） with an average recovery rates of it at low,medium and high concentrations were 100. 41%,104. 03% and 103. 66 %（ RSD = 1. 82%）. The linear range of dexamethasone was1. 24-12. 4 μg / m L（ r = 0. 999 9） with an average recovery rates of it at low,medium and high concentrations were 99.95%,104. 70% and 103. 59%（ RSD = 2. 18%）. Conclusions The established method is simple, accurate and reproducible. It can be used for the quality control of Fuyan ointment.