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目的:建立同时测定特益乳膏中盐酸特比萘芬和硝酸益康唑含量的HPLC方法。方法:采用Hypersil ODS_2色谱柱(250mm×4.6mm,5μm),流动相为甲醇-磷酸盐缓冲液(取磷酸二氢钾与磷酸氢二钾各2.5g,加水溶解并稀释至1000ml)(85:15),流速:1.0ml·min~(-1),柱温:25℃;检测波长为232nm。结果:盐酸特比萘芬在80.0～640.0μg·ml~(-1)范围内呈良好的线性关系(r=0.9993),平均回收率分别为100.69%、100.97%、99.06%;硝酸益康唑在20.0～200.0μg·ml~(-1)范围内呈良好的线性关系(r=0.9991),平均回收率分别为101.41%、99.68%、98.56%。结论:建立的方法准确、可靠,可用于特益乳膏的质量控制。
OBJECTIVE: To establish an HPLC method for the simultaneous determination of terbinafine hydrochloride and econazole nitrate in Teyi Cream. METHODS: Hypersil ODS_2 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase consisted of methanol-phosphate buffer (2.5 g each of potassium dihydrogenphosphate and dipotassium hydrogenphosphate, dissolved in water and diluted to 1000 ml) 15), flow rate: 1.0ml · min -1, column temperature: 25 ℃; detection wavelength was 232nm. Results: Terbinafine hydrochloride showed a good linearity (r = 0.9993) in the range of 80.0 ~ 640.0μg · ml ~ (-1) with the average recoveries of 100.69%, 100.97% and 99.06%, respectively. In the range of 20.0 ~ 200.0μg · ml ~ (-1), there was a good linear relationship (r = 0.9991). The average recoveries were 101.41%, 99.68% and 98.56% respectively. Conclusion: The established method is accurate and reliable, and can be used for the quality control of special benefits cream.