HPLC法同时测定曲安奈德苯海拉明水杨酸酊中三种有效成分的含量

Simultaneous Determination of Three Active Components in Triamcinolone Diphenhydramine Salicylic Acid Tincture by HPLC

目的建立同时测定曲安奈德苯海拉明水杨酸酊中的醋酸曲安奈德、盐酸苯海拉明和水杨酸含量的HPLC方法。方法色谱柱为资生堂CAPCELL PAK C18 MGⅡ(250 mm×4.6 mm,5μm),以甲醇-水(每1000 mL水中加三乙胺7 mL,磷酸调节pH值为7.2)(70∶30)为流动相,流速为1.0 mL/min,检测波长为240 nm,柱温为35℃。结果醋酸曲安奈德进样量在0.026~0.309μg质量范围内呈良好的线性关系,回归方程:y=1930.7703x+1.7056(r=1.0000),平均加标回收率为99.8%,RSD为1.03%(n=9)。盐酸苯海拉明进样量在0.499~5.988μg质量范围内呈良好的线性关系,回归方程:y=82.8673x+2.4236(r=0.9999),平均加标回收率为99.2%,RSD为1.18%(n=9)。水杨酸进样量在0.506~6.072μg质量范围内呈良好的线性关系,回归方程:y=1310.1096x+227.5138(r=0.9964),平均加标回收率为103.5%,RSD为0.81%(n=9)。结论所建立的测定方法简单、易行、重现性好,专属性强,可用于曲安奈德苯海拉明水杨酸酊的含量测定。

Objective To establish a HPLC method for simultaneous determination of triamcinolone acetonide acetate,diphenhydramine hydrochloride and salicylic acid in triamcinolone diphenhydramine salicylic acid tincture.Methods The chromatography was performed on Shiseido CAPCELL PAK C18 MGⅡ(250 mm×4.6 mm,5μm)column,the mobile phase was methanol-water(7 mL triethylamine per 1000 mL of water,pH adjusted to 7.2 by phosphoric acid)(70∶30),the flow rate was 1.0 mL/min,and the detection wavelength was 240 nm,the column temperature was 35℃.Results The mass concentration of triamcinolone acetonide acetate showed a good linear relationship in the range of 0.026 to 0.309μg,the regression equation was y=1930.7703x+1.7056(r=1.0000),the average recovery rate was 99.8%,RSD was 1.03%(n=9).Diphenhydramine hydrochloride showed a good linear relationship in the range of 0.499 to 5.988μg,the regression equation was y=82.8673x+2.4236(r=0.9999),the average recovery rate was 99.2%,RSD was 1.18%(n=9).Salicylic acid concentration showed a good linear relationship in the range of 0.506 to 6.072μg,the regression equation was y=1310.1096x+227.5138(r=0.9964),the average recoveries rate was 103.5,RSD was 0.81%(n=9).Conclusion The established method is simple,easy,reproducible and specific,and can be used for the determination of triamcinolone diphenhydramine salicylic acid tincture.