Analysis of docosanol using GC/MS:Method development,validation,and application to ex vivo human skin permeation studies  

作　　者：Vijay Kumar Shankar Mei Wang Srinivas Ajjarapu Praveen Kolimi Bharathi Avula Reena Murthy Ikhlas Khan Sathyanarayana Narasimha Murthy 

机构地区：[1]Department of Pharmaceutics and Drug Delivery,University of Mississippi,Oxford,MS,38677,USA [2]Natural Products Utilization Research Unit,Agricultural Research Service,U.S.Department of Agriculture,Oxford,MS,38677,USA [3]National Center for Natural Products Research,Research Institute of Pharmaceutical Sciences,School of Pharmacy,University of Mississippi,Oxford,MS,38677,USA [4]Topical Products Testing LLC,Oxford,MS,38677,USA

出　　处：《Journal of Pharmaceutical Analysis》2022年第2期287-292,共6页药物分析学报（英文版）

摘　　要：Docosanol is the only US Food and Drug Administration(FDA)approved over-the-counter topical product for treating recurrent oral-facial herpes simplex labialis.Validated analytical methods for docosanol are required to demonstrate the bioequivalence of docosanol topical products.A gas chromatography/selected ion monitoring mode mass spectrometry(GC/SIM-MS)method was developed and validated for docosanol determination in biological samples.Docosanol and isopropyl palmitate(internal standard)were separated on a high-polarity GC capillary column with(88%cyanopropy)aryl-polysiloxane employed as the stationary phase.The ions of m/z 83 and 256 were selected to monitor docosanol and isopropyl palmitate,respectively;the total run time was 20 min.The GC/SIM-MS method was validated in accordance with US FDA guidelines,and the results met the US FDA acceptance criteria.The docosanol calibration standards were linear in the 100-10000 ng/mL concentration range(R^(2)>0.994).The recoveries for docosanol from the receptor fluid and skin homogenates were>93.2%and>95.8%,respectively.The validated method was successfully applied to analyze ex vivo human cadaver skin permeation samples.On applying Abreva®cream tube and Abreva®cream pump,the amount of docosanol that penetrated human cadaver skin at 48 h was 21.5±7.01 and 24.0±6.95 ng/mg,respectively.Accordingly,we concluded that the validated GC/SIM-MS was sensitive,specific,and suitable for quantifying docosanol as a quality control tool.This method can be used for routine analysis as a costeffective alternative to other techniques.

关 键 词：Docosanol Fatty alcohols Gas chromatography-mass spectrometry Topical formulation Skin permeation 

分 类 号：R96[医药卫生—药理学]