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目的:采用HPLC法同时测定双唑泰软膏中甲硝唑、克霉唑和醋酸氯己定的含量。方法:使用Agilent HC-C_(18)(2)柱(250 mm×4.6 mm,5μm),流动相为甲醇-pH 3.6缓冲液(醋酸钠20.4 g,加冰醋酸80 ml,加1 mol·L~(-1)四丁基溴化铵溶液10ml,加水至1000 ml)(70:30),柱温30℃,流速为1.0 ml·min~(-1),检测波长为262 nm。结果:甲硝唑、克霉唑和醋酸氯己定的线性范围分别为:0.082～0.410 mg·ml~(-1)(r=0.999 9),0.066～0.330 mg·ml~(-1)(r=0.999 8)和3.20～16.08μg·ml~(-1)(r=0.999 8);平均回收率分别为99.8%,99.4%和100.1%,RSD分别为0.73%、0.63%和0.66%。结论:该方法快速、简便,分离度好,其他成分无干扰,适用于控制产品质量。
Objective: To determine the contents of metronidazole, clotrimazole and chlorhexidine acetate in bifonazole ointment simultaneously by HPLC. METHODS: The mobile phase consisted of methanol-pH 3.6 buffer (20.4 g of sodium acetate, 80 ml of glacial acetic acid and 1 mol·L-1 of acetonitrile) on an Agilent HC-C 18 column (250 mm × 4.6 mm, (-1) tetrabutylammonium bromide solution (10ml, add water to 1000ml) (70:30). The column temperature was 30 ℃, the flow rate was 1.0 ml · min -1 and the detection wavelength was 262 nm. Results: The linear ranges of metronidazole, clotrimazole and chlorhexidine acetate were 0.082-0.410 mg · ml -1 (r = 0.999 9) and 0.066-0.330 mg · ml -1 ( r = 0.999 8) and 3.20-16.08 μg · ml -1 (r = 0.999 8). The average recoveries were 99.8%, 99.4% and 100.1%, respectively, with RSDs of 0.73%, 0.63% and 0.66%, respectively. Conclusion: The method is rapid, simple, good resolution, no interference of other components, suitable for controlling product quality.