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目的:建立以高效液相色谱法测定复方硝酸咪康唑乳膏中硝酸咪康唑、醋酸曲安奈德、盐酸苯海拉明含量的方法。方法:色谱柱为Hypersil ODS2,流动相为甲醇-乙腈-0.5%醋酸铵(45∶35∶20),流速为1.0mL·min-1,检测波长为234nm,柱温为40℃,进样量为20μL。结果:硝酸咪康唑、醋酸曲安奈德和盐酸苯海拉明检测浓度的线性范围分别为0.16～0.64(r=0.9998)、0.02～0.06(r=0.9999)、0.08～0.24(r=0.9992)mg·mL-1,平均回收率分别为100.0%、99.6%、100.7%,RSD分别为1.2%、0.8%、0.9%(n=3)。结论:本方法可同时测定该制剂中3组分的含量。
Objective: To establish a method for the determination of miconazole nitrate, triamcinolone acetonide and diphenhydramine hydrochloride in compound miconazole nitrate cream by HPLC. Methods: The chromatographic column was Hypersil ODS2. The mobile phase was methanol-acetonitrile-0.5% ammonium acetate (45:35:20), the flow rate was 1.0 mL · min-1, the detection wavelength was 234 nm and the column temperature was 40 ℃. 20μL. Results: The linear range of miconazole nitrate, triamcinolone acetonide and diphenhydramine hydrochloride were 0.16 ~ 0.64 (r = 0.9998), 0.02 ~ 0.06 (r = 0.9999) and 0.08 ~ 0.24 (r = 0.9992) mg · mL-1. The average recoveries were 100.0%, 99.6% and 100.7%, respectively. The RSDs were 1.2%, 0.8% and 0.9% respectively (n = 3). Conclusion: The method can simultaneously determine the content of 3 components in the preparation.