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

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Journal of Pharmaceutical Analysis 2022年第2期12卷 287-292页

作者： 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 MississippiOxfordMS38677USA Natural Products Utilization Research Unit Agricultural Research ServiceU.S.Department of AgricultureOxfordMS38677USA National Center for Natural Products Research Research Institute of Pharmaceutical SciencesSchool of PharmacyUniversity of MississippiOxfordMS38677USA Topical Products Testing LLC OxfordMS38677USA

Docosanol is the only US Food and Drug Administration(FDA)approved over-the-counter topical product for treating recurrent oral-facial herpes simplex *** 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 *** and isopropyl palmitate(internal standard)were separated on a high-polarity GC capillary column with(88%cyanopropy)aryl-polysiloxane employed as the stationary *** ions of m/z 83 and 256 were selected to monitor docosanol and isopropyl palmitate,respectively;the total run time was 20 *** GC/SIM-MS method was validated in accordance with US FDA guidelines,and the results met the US FDA acceptance *** 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%,*** validated method was successfully applied to analyze ex vivo human cadaver skin permeation *** 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,***,we concluded that the validated GC/SIM-MS was sensitive,specific,and suitable for quantifying docosanol as a quality control *** 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

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