HPLC测定硝酸舍他康唑尿素乳膏中硝酸舍他康唑的含量

Determination of Sertaconazole Nitrate in Sertaconazole Nitrate and Urea Cream Formulation by HPLC

关键词:  硝酸舍他康唑  硝酸舍康他唑尿素乳膏  高效液相色谱法  含量测定

Key words:  sertaconazole nitrate  sertaconazole nitrate and urea cream  HPLC  content determination

摘要:

目的 建立高效液相色谱法测定硝酸舍他康唑尿素乳膏中硝酸舍他康唑的含量。方法 色谱柱：Hypersil C₁₈(4.6 mm×250 mm，5 μm)；流动相：乙腈-0.01 mol·L^-1磷酸氢二钠溶液(用稀磷酸调pH=7.0)(37∶63)；流速：1.0 mL·min^-1；检测波长：260 nm。结果 硝酸舍他康唑在20.4~102.0 μg·mL^-1内线性关系良好(r=0.999 3)，平均回收率为99.55%，RSD=0.73%(n=6)。结论 此法操作简便、结果准确、精密度好，可用于硝酸舍他康唑尿素乳膏的质量控制。

Abstract:

OBJETCTIVE A high-performance liquid chromatographic method was developed for the determination of sertaconazole nitrate in sertaconazole nitrate and urea cream formulation. METHODS Hypersil C18 column (4.6 mm×250 mm, 5 μm) was used along with a mobile phase consisting of acetonitrile-0.01 mol·L^-1 disodium hydrogen phosphate solution(37∶63), adjusted to pH 7.0 by phosphoric acid. The flow rate was 1.0 mL·min^-1, and the detection wavelength was 260 nm. RESULTS The detector response for sertaconazole nitrate is linear over the concentration range of 20.40-102.0 μg·mL^-1, and the average recovery was 99.55%(RSD=0.73%, n=6). CONCLUSION The method is simple and accurate, it can be used for quality control of sertaconazole nitrate and urea cream formulation.