高效液相色谱法测定皮肤透过液中酮康唑浓度  

Determination of Ketoconazole in Skin Penetration Solution by HPLC

作　　者：苏碧雅[1] 李国锋[1] 刘思佳[1] 熊璐琪[1] 

机构地区：[1]南方医科大学南方医院药学部,广州510515

出　　处：《医药导报》2012年第5期565-567,共3页Herald of Medicine

基　　金：广东省自然科学基金(9151008901000223);广东省科技计划项目(2008B060600068)

摘　　要：目的建立测定Franz实验制得的皮肤透过液中酮康唑浓度的高效液相色谱法,为研究酮康唑经皮给药后药动学奠定基础。方法采用高效液相色谱法测定皮肤透过液中酮康唑浓度,ECOSIL C18色谱柱(250 mm×4.6 mm,5μm),流动相:甲醇-0.02 mol.L-1磷酸二氢钾溶液(70∶30,用0.01 mol.L-1氢氧化钠溶液调节pH至6.8),流速:1.0 mL.min-1,柱温35℃,紫外检测波长235 nm。结果酮康唑线性范围0.05～25.00μg.mL-1(r=0.999 3)。高、中、低浓度平均回收率98.109%,RSD=2.956%(n=9),日内精密度和日间精密度RSD均<3.30%。结论该方法测定酮康唑乳膏皮肤透过液中的酮康唑含量快速、简捷,可用于酮康唑乳膏剂的质量控制和酮康唑经皮吸收研究。Objective To establish a method for determination of ketoconazole in skin penetration solution prepared by the Franz experiment with HPLC,providing evidence for pharmacokinetics study of ketoconazole via posttransdermal administration.Methods HPLC was performed on ECOSIL C18 column（250 mm×4.6 mm,5 μm） at 35 ℃,and the mobile phase was composed of methanol-0.02 mol·L-1 KH2PO4 solution（70：30）（pH value being adjusted to 6.8 with 0.1 mol·L-1 NaOH solution）.The flow rate was 1.0 mL·min-1,and the detection wavelength was 235 nm.Results The linear range of ketoconazole was within 0.05-25.00 μg·mL-1（r=0.999 3）.The average recovery of the solution at high,middle,and low concentration was 98.109% with RSD as 2.956%,repectively,and both of the intra-day and inter-day precision were3.30%.Conclusion The method is rapid and simple,and can be used for the quality control of ketoconazole cream and research on percutaneous of absorption ketoconazole.

关 键 词：酮康唑 经皮透过 色谱法 高效液相 

分 类 号：R978[医药卫生—药品] R965[医药卫生—药学]