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Validation of a reversed-phase high-performance liquid chromatography (RP-HPLC) method for analysis of [11C]Nicotine

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Abstract

Validated analytical methods must be used for accurate and precise determination of identity, purity, strength, and quality of any pharmaceutical dose intended for human administration. Consequently, all analytical methods must be validated per USP <1225> and the ICH Q2R1 guidelines to meet the cGMP requirements of the FDA and EMA. A reversed-phase high-performance liquid chromatography analytical method, with <10 min run time, was developed for the analysis of [11C]nicotine. The analytical method was found to be specific, accurate, suitable, robust, precise, and linear for [11C]nicotine, nicotine, and (±) nornicotine in the concentration ranges studied. The LOD and LOQ values were also established.

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Acknowledgment

This study was supported by the Wright Center of Innovation Development fund and an Imaging and Radiation Oncology Core (IROC) grant from the American College of Radiology (U24CA80803).

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Authors and Affiliations

  1. Laboratory for Translational Research in Imaging Pharmaceuticals, The Wright Center of Innovation in Biomedical Imaging, Department of Radiology, The Ohio State University, Columbus, OH, 43212, USA

    Arijit Ghosh, Karen Woolum, Michael V. Knopp & Krishan Kumar

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  1. Arijit Ghosh
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  2. Karen Woolum
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  3. Michael V. Knopp
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  4. Krishan Kumar
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Correspondence to Krishan Kumar.

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Ghosh, A., Woolum, K., Knopp, M.V. et al. Validation of a reversed-phase high-performance liquid chromatography (RP-HPLC) method for analysis of [11C]Nicotine. J Radioanal Nucl Chem 326, 1719–1725 (2020). https://doi.org/10.1007/s10967-020-07467-0

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  • DOI: https://doi.org/10.1007/s10967-020-07467-0

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