HPLC法测定联苯苄唑乳膏中尼泊金酯的含量

Determination of Nipagin Ester in Bifonazole Cream by HPLC

用高效液相色谱法测定了联苯苄唑乳膏中的防腐剂尼泊金酯的含量。用甲醇-水作流动相,建立了同时测定联苯苄唑乳膏中尼泊金甲酯和乙酯的高效液相色谱方法。色谱柱Hypersil C18-ODS(4.6 mm×250 mm,5μm),检测波长为254 nm,流动相V甲醇︰V水=70︰30,流速为1.00 mL/min。经测定,尼泊金甲酯和尼泊金乙酯的平均回收率分别为97.4%和101.8%,联苯苄唑外用乳膏中尼泊金甲酯、乙酯含量分别为3.93×10-5 mol/L与1.45×10-5 mol/L,即0.860 mg/g样品和0.350 mg/g样品。含量测定重复性RSD分别为0.84%、0.35%。结论:该方法操作简单,结果较好,可用于药品中尼泊金酯含量的测定。

High performance liquid chromatography is used to determine the content of preservative nipagin esters in Bifonazole cream.Using methanol-water as the mobile phase,HPLC was applied to the determination of Parabens in the Bifonazole cream.The Hyper C18-ODS(4.6 mm×250 mm,5μm)was used as the stationary phase.UV-detection at the wavelength of 254 nm,and an mixed solution of ethanol-water in the ration of 70 to 30(by volume)was used as the mobile phase,the flow rate of mobile phase was 1.0 mL/min.Through determining,the average recovery was 97.4%and 101.8%respectively,the content of parabens in bifonazole cream is 3.93×10-5 mol/L and 1.45×10-5 mol/L respectively.It meaned that 0.860 mg/g methyl Paraben and 0.350 mg/g ethyl Paraben was found in Bifonazole cream,and good reproducibility(RSD 0.84%,0.35%respectively)was obtained for the assay.Conclusion:the method operated simply and had good results.HPLC can be used widely in the quantitative determination of parabens in bifonazole cream.