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目的:建立一种反相高效液相色谱测定法,同时测定复方特比奈芬乳膏中二组分的含量。方法:采用Kromasil-C18柱(150 mm×4.6 mm,5μm);流动相为甲醇-醋酸铵缓冲液(1.15g醋酸铵+水300 mL+冰醋酸1 mL用三乙胺调pH至5~6)(70∶30)。采用变流速洗脱方式:1~8 min流速为1.0 mL.min-1,此后按线性梯度增加流速,至10 min时为1.5 mL.min-1,并维持该流速至25 min。检测波长为254 nm。结果:盐酸特比奈芬与曲安奈德分离良好(R>2.0)且不受基质成分的干扰;上述2种成分分别在100~1 600μg.mL-1和10~160μg.mL-1范围内具有良好的线性关系(r=0.999 9和r=0.999 9),回收率分别为98.7%~100%(盐酸特比奈芬),98.2%~99.8%(曲安奈德)。结论:该方法专属性强,精密度高,可同时测定制剂中盐酸特比奈芬和曲安奈德二组分的含量,操作简便,可作为该制剂质量控制标准。
Objective: To establish a reversed-phase high performance liquid chromatography (HPLC) assay for simultaneous determination of two components in compound terbinafine cream. METHODS: Kromasil-C18 column (150 mm × 4.6 mm, 5 μm) was used. The mobile phase consisted of methanol-ammonium acetate buffer (1.15 g ammonium acetate + water 300 mL and glacial acetic acid 1 mL pH adjusted to 5-6 with triethylamine) (70:30). The flow rate was changed to 1.0 mL.min-1 at 1 ~ 8 min, then increased linearly to 1.5 mL.min-1 at 10 min, and the flow rate was maintained at 25 min. The detection wavelength is 254 nm. RESULTS: Terbinafine hydrochloride was well separated from triamcinolone acetonide (R> 2.0) and was not disturbed by matrix components. The two components were found to be in the range of 100-1 600 μg.mL-1 and 10-160 μg.mL-1, respectively (R = 0.999 9 and r = 0.999 9). The recoveries were 98.7% ~ 100% (terbinafine hydrochloride) and 98.2% ~ 99.8% (triamcinolone acetonide) respectively. Conclusion: The method is specific and precise, and can be used for the simultaneous determination of terbinafine hydrochloride and triamcinolone acetonide in the preparation. The method is simple and easy to operate and can be used as a quality control standard.