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Development and validation of a high-performance thin-layer chromatography assay for the analysis of tacrolimus ointments

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Abstract

A simple and rapid high-performance thin-layer chromatography (HPTLC) assay was developed and validated for the quantification of tacrolimus ointments on silica gel 60 F254 HPTLC plates, using toluene–acetonitrile–ethyl acetate–glacial acetic acid (6:2:2:0.1, V/V) as the mobile phase and p-anisaldehyde‒sulphuric acid as the derivatising reagent. The analysis was performed at 366 nm. The method was fully validated according to the International Council for Harmonisation guidelines and found to be sensitive, precise, accurate and reproducible with tacrolimus presenting as a sharp band at RF 0.20, good linear regression between 20 and 140 ng/band (r2 = 0.9989) and sensitivity levels in terms of limit of detection and limit of quantification of 5.68 ng and 17.20 ng, respectively. The method is therefore deemed suitable for the routine quality control analysis of tacrolimus ointments.

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Acknowledgements

We would like to thank the WA Hospital’s Central Pharmaceutical Manufacturing Facility (Auspman) for supply of some of the consumables used in this study as well as excess to their extemporaneous tacrolimus formulations.

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Authors and Affiliations

  1. Division of Pharmacy, School of Allied Health, University of Western Australia, Crawley, WA, 6009, Australia

    Md Khairul Islam, Jemma Keay, Yasmin Hussenbocus, Aaron Svagelj, David Lam, Tomislav Sostaric, Minh Nguyen, Lee Yong Lim & Cornelia Locher

  2. Chromatech Scientific Pty Ltd., Yangebup, WA, 6164, Australia

    Tomislav Sostaric

  3. Auspman (Western Australian Hospitals Central Pharmaceutical Manufacturing Facility), Perth Children Hospital, Nedlands, WA, 6009, Australia

    Spencer Skett

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  1. Md Khairul Islam
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  2. Jemma Keay
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  3. Yasmin Hussenbocus
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  7. Minh Nguyen
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  8. Lee Yong Lim
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  9. Spencer Skett
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  10. Cornelia Locher
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Correspondence to Cornelia Locher.

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Islam, M.K., Keay, J., Hussenbocus, Y. et al. Development and validation of a high-performance thin-layer chromatography assay for the analysis of tacrolimus ointments. JPC-J Planar Chromat 34, 189–195 (2021). https://doi.org/10.1007/s00764-021-00105-9

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  • DOI: https://doi.org/10.1007/s00764-021-00105-9

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