Development and application of a chromatographic method for simultaneous quantification of 5-fluorouracil and imiquimod in drug-in-adhesive topical patches
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2022
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Kim, S.
Youssef, S.H.
Song, Y.
Garg, S.
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Sustainable Chemistry and Pharmacy, 2022; 27
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Topical patches containing 5-fluorouracil and imiquimod would significantly improve the shortcomings of the marketed semi-solid formulations for the treatment of non-melanoma skin cancer. As an analytical method is a fundamental part of formulation development, in this study, a simple, accurate, sensitive and greener analytical method was developed and validated for the simultaneous quantification of 5-fluorouracil and imiquimod. The optimal chromatographic conditions were obtained using a C18 column (250 × 4.6 mm, 5 μm), mobile phase containing 0.1 M sodium acetate buffer (pH 4) and acetonitrile (60:40, v/v), a flow rate of 1 mL/min and injection volume of 10 μL at 25 °C. Signals were detected at 244 nm and 265 nm for imiquimod and 5-fluorouracil, respectively. Validation procedures were performed according to the United States Food and Drug Administration guidelines and the linearity range was found to be 0.78 – 50 μg/mL for both 5-fluorouracil and imiquimod. Other parameters including accuracy, precision, robustness, selectivity and stability were within the acceptable limits. The proposed method was successfully applied to determine the 5-fluorouracil and imiquimod contents simultaneously and their release profiles of a drug-in-adhesive patch. Furthermore, the greenness of the proposed analytical method was comprehensively determined using various greenness evaluation tools.
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Copyright 2022 Elsevier
Access Condition Notes: Accepted manuscript available after 1 July 2024