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目的:建立用HPLC法测定盐酸特比萘芬乳膏含量的方法。方法:采用Hypersil ODS_2柱(250 mm×4.6 mm,5μm);流动相为四氢呋喃-乙腈-四甲基氢氧化铵缓冲液(15∶60∶25);检测波长为280 nm;柱温25℃;流速1.0 ml·min~(-1)。结果:盐酸特比萘芬在121.08～282.52μg·ml~(-1)的浓度范围内与峰面积呈良好的线性关系(r=0.9999);平均回收率为98.4%,RSD为1.7%。结论:本法简单、快速、精确、重复性好,可作为产品的质量控制方法。
Objective: To establish a HPLC method for the determination of terbinafine hydrochloride cream. METHODS: Hypersil ODS_2 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase was tetrahydrofuran-acetonitrile-tetramethylammonium hydroxide buffer (15:60:25). The detection wavelength was 280 nm. Flow rate 1.0 ml · min ~ (-1). Results: Terbinafine hydrochloride showed a good linear relationship with the peak area in the range of 121.08-282.52μg · ml -1 (r = 0.9999). The average recovery was 98.4% and the RSD was 1.7%. Conclusion: This method is simple, rapid, accurate and reproducible. It can be used as the quality control method of the product.