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目的:测定克霉唑乳膏中尼泊金酯的含量。方法:高效液相法色谱柱:Alltech C18柱(4.6 mm×250mm,5μm),检测波长:254 nm。用甲醇-水作流动相分析尼泊金酯混合物。结果:用高效液相色谱分析方法测定,尼泊金甲酯、丙酯的线性范围分别为4.75～31.67μg/mL和5.63～37.50μg/mL,平均回收率分别为100.59%、99.64%,样品中尼泊金甲酯和丙酯的质量分数分别为0.135%(g/g)、0.0807%(g/g),含量测定重复性RSD分别为0.82%、1.82%。结论:建立了同时测定克霉唑乳膏中对羟基苯甲酸、甲酯和丙酯的高效液相色谱分析方法,该方法操作简单,结果较好,能够广泛应用于尼泊金酯含量的测定。
OBJECTIVE: To determine the content of nipagin in clotrimazole cream. Methods: High performance liquid chromatography column: Alltech C18 column (4.6 mm × 250 mm, 5 μm), detection wavelength: 254 nm. The paraben mixture was analyzed with methanol-water as the mobile phase. Results: The linear ranges of methylparaben and propylparaben were 4.75 ~ 31.67μg / mL and 5.63 ~ 37.50μg / mL, respectively. The average recoveries were 100.59% and 99.64%, respectively. The sample The mass fraction of methylparaben and propylpropionate were 0.135% (g / g) and 0.0807% (g / g) respectively, and the repeatability RSDs were 0.82% and 1.82% respectively. CONCLUSION: A high performance liquid chromatography (HPLC) method for the simultaneous determination of p-hydroxybenzoate, methyl ester and propyl ester in clotrimazole cream was established. The method is simple and has good results. It can be widely used in the determination of nipagin ester content .