HPLC法同时测定复方醋酸氟氢松酊中水杨酸、间苯二酚和醋酸氟轻松的含量

Simultaneous Determination of Salicylic Acid,Resorcinol and Fluocinolone Acetonide in Compound Fluocinonide Tincture by HPLC

目的建立HPLC法测定复方醋酸氟氢松酊中水杨酸、间苯二酚和醋酸氟轻松的含量。方法采用Venusil MP C_(18)柱(4.6 mm×250 mm,5μm)色谱柱;以1%冰醋酸溶液(用三乙胺调节pH值至3.0)为流动相A,以甲醇为流动相B,梯度洗脱;流速为1.0 mL·min^(-1);检测波长为240 nm、276 nm;柱温35℃。结果水杨酸、间苯二酚和醋酸氟轻松3个成分浓度分别在0.0540~1.081μg·mL^(-1)(r=0.9999,n=6)、0.0866~1.733μg·mL^(-1)(r=0.9998,n=6)、0.00813~0.0813μg·mL^(-1)(r=1.0000,n=5)的范围内与峰面积呈现良好的线性关系;方法平均回收率(n=9)分别为100.7%、100.1%、100.2%。结论该方法简便、准确、重现性好,专属性强,可用于复方醋酸氟轻松酊的含量测定及质量控制。

OBJECTIVE To establish a HPLC method for simultaneous determination of salicylic acid,resorcinol and fluocinolone acetonide in compound fluocinonide tincture.METHODS The HPLC method was performed on a Venusil MP C_(18)(4.6 mm×250 mm,5μm)by gradient elution.The 1%acetic acid(adjust the pH to 3.0 with triethylamine)and the methanol were used as the mobile phase A and B.The flow rate was at 1.0 mL·min^(-1)with the column temperature at 35℃.The detection wavelength was at 240,276 nm,respectively.RESULTS The linear range of salicylic acid,resorcinol and fluocinolone acetonide were 0.0540-1.081μg·mL^(-1)(r=0.9999,n=6),0.0866-1.733μg·mL^(-1)(r=0.9998,n=6),0.00813-0.0813μg·mL^(-1)(r=1.0000,n=5),respectively.The average recoveries(n=9)were 100.7%,100.1%,100.2%,respectively.CONCLUSION The method is simple,accurate,repeatable and specificity,and can be used for quality control of compound fluocinonide tincture.