HPLC法测定联苯苄唑乳膏中尼泊金酯的含量

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。

Pharmacokinetics of two components in felodipine-enalapril sustained-release tablets in Chinese healthy volunteers

To compare the pharmacokinetics properties of enalapril-felodipine sustained-release tablet with enalapril and felodipine in the two reference formulations in Chinese healthy volunteers, the study was designed to a randomized, open label, crossover and two treatment pharmacokinetic study using enalapril-felodipine sustatined-release tablet as the test formulation. A total of 12 individuals were randomly assigned to 2 gorups （6 individuals in each group）. The wash-out period was 14 d. Compared with the reference formulations, felodipine in the sustained-release tablet showed significantly sustained-release characteristics, while the pharmacokinetics processes of enalapril and its active metabolite enalaprilat were basically similar in Chinese healthy volunteers.