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

Journal: Journal of pharmaceutical analysis
Published Date: Aug 29, 2021

Abstract

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 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 ( >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 cost-effective alternative to other techniques.

Authors

  • Vijay Kumar Shankar
    Department of Pharmaceutics and Drug Delivery, University of Mississippi, Oxford, MS, 38677, USA.
  • Mei Wang
    Natural Products Utilization Research Unit, Agricultural Research Service, U.S. Department of Agriculture, Oxford, MS, 38677, USA.
  • Srinivas Ajjarapu
    Department of Pharmaceutics and Drug Delivery, University of Mississippi, Oxford, MS, 38677, USA.
  • Praveen Kolimi
    Department of Pharmaceutics and Drug Delivery, University of Mississippi, Oxford, MS, 38677, USA.
  • Bharathi Avula
    National Center for Natural Products Research, Research Institute of Pharmaceutical Sciences, School of Pharmacy, University of Mississippi, Oxford, MS, 38677, USA.
  • Reena Murthy
    Topical Products Testing LLC, Oxford, MS, 38677, USA.
  • Ikhlas Khan
    National Center for Natural Products Research, Research Institute of Pharmaceutical Sciences, School of Pharmacy, University of Mississippi, Oxford, MS, 38677, USA.
  • Sathyanarayana Narasimha Murthy
    Topical Products Testing LLC, Oxford, MS, 38677, USA.

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