克霉唑乳膏中尼泊金酯含量的测定

Quantitative Determination of Parabens in Clotrimazole cream

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 Determination of Parabens in Clotrimazole cream in content.Methods: HPLC column: Alltech C18 column(4.6 mm×250 mm,5 μm),the detecting wavelength was at 254 nm.The linear law in the spectra obtained from the high performance liquid chromatography was investigated,using methanol-water as the mobile phase.The high performance liquid chromatography method of determining the nipagin and nipasol simultaneously in the Clotrimazole cream was established.Results Determination Parabens in the range of 4.75～31.67μg/mL and 5.63～37.50 μg/mL,average recovery of 100.59 percent and 99.64 percent respectively,the average content of methyl and propyl parabens in samples are 1.353 mg/g and 0.807 mg/g respectively,and good reproducibility(espectively RSD 0.82%,1.82 %) was obtained for the assay.Conclusion The high performance liquid chromatograpy method of determing the nipasol and nipasol simultaneously in the Clotrimazole cream was established,The method is simple,good results can be widely used in Parabens in the deternination.