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(R2＞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 doco-sanol 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 cost-effective alternative to other techniques.

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

Department of Pharmaceutics and Drug Delivery,University of Mississippi,Oxford,MS,38677,USA;Natural Products Utilization Research Unit,Agricultural Research Service,U.S.Department of Agriculture,Oxford,MS,38677,USA;National Center for Natural Products Research,Research Institute of Pharmaceutical Sciences,School of Pharmacy,University of Mississippi,Oxford,MS,38677,USA;Topical Products Testing LLC,Oxford,MS,38677,USA

药物分析学报（英文）

[1]Vijay Kumar Shankar;Mei Wang;Srinivas Ajjarapu;Praveen Kolimi;Bharathi Avula;Reena Murthy;Ikhlas Khan;Sathyanarayana Narasimha Murthy-.Analysis of docosanol using GC/MS:Method development,validation,and application to ex vivo human skin permeation studies)[J].药物分析学报（英文）,2022(02):287-292

docosanol,Docosanol,labialis,cyanopropy,homogenates,cadaver,Abreva,doco,sanol

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