派瑞松乳膏中曲安奈德和硝酸益康唑的含量测定

Determination of Triamcinolone Acetonide and Econazole Nitrate in Triamcinolone Acetonide and Econazole Nitrate Cream by HPLC

目的建立派瑞松乳膏中曲安奈德和硝酸益康唑的含量测定方法。方法采用高效液相色谱(HPLC)法测定,色谱柱为Kromasil ODS-1柱(200mm×4.6mm,5μm),流动相为0.5%三乙胺(醋酸调节pH为3.0)-甲醇(50:50),检测波长为240nm,流速为1mL/min。结果曲安奈德和硝酸益康唑质量浓度分别在6.06～80.80μg/mL和60.75～810.00μg/mL范围内与峰面积线性良好,r分别为0.9994和0.9998,平均回收率分别为101.43%和100.70%,RSD为1.28%和1.58%(n=9)。结论HPLC法操作简便,分离效果好,灵敏度高,重现性好,为控制派瑞松乳膏质量提供了依据。

Objective To establish a method for the determination of triamcinolone acetonide and econazole nitrate in Triamcinolone Ace- tonide and Econazole Nitrate Cream. Methods The Kromasil ODS- 1（200×4.6 mm） was used. The mobile phase consisted of MeOH- 0. 5%TEA（pH =3.0, HAC）（50：50）. The flow rate was 1 mL/min. The UV detection wavelength was 240 nm. Results The calibration curves of triamcinolone acetonide and econazole nitrate were in good linearity over the range of 6.06-80. 80 μg/mL, 60.75-810. 00μg/mL, （r=0. 999 4, 0. 999 8）, respectively. The average recovery rates were 101.43% and 100. 70%, RSD were 1.28% and 1.58% （n =9）, respectively. Conclusion The method is simple, sensitive, accurate and reproducible. It can be used to control the quality of Triamcinolone Acetonide and Econazole Nitrate Cream.