Faculty and Student Publications
Document Type
Article
Publication Date
4-1-2022
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 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 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.
Relational Format
journal article
Recommended Citation
Shankar, V. K., Wang, M., Ajjarapu, S., Kolimi, P., Avula, B., Murthy, R., Khan, I., & Murthy, S. N. (2022). Analysis of docosanol using GC/MS: Method development, validation, and application to ex vivo human skin permeation studies. Journal of Pharmaceutical Analysis, 12(2), 287–292. https://doi.org/10.1016/j.jpha.2021.08.004
DOI
10.1016/j.jpha.2021.08.004
Accessibility Status
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