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Quantitative chromatographic method development for residual lidocaine in topical systems and biological samples: supplementary materials

posted on 2023-05-18, 15:41 authored by Jayshil A Bhatt, Hui Wei, Armita Azarpanah, Kenneth R Morris, Qing Cai

Background: The aim of this work was to develop and validate sensitive and efficient analytical methods

for estimating systemic drug exposure and residual drug following the application of topical delivery

systems. Materials & methods: Lidocaine was extracted using a liquid–liquid extraction technique from

commercial topical products and analyzed using ultra high-performance liquid chromatography. A

separate LC–MS/MS method was developed for analyzing human serum samples. Results & conclusion:

The developed methods were successfully applied for estimating lidocaine content in two commercial

products demonstrating 97.4–104.0% for product A and 105.0–110.7% for product B. The LC–MS/MS

method displayed successful analysis of lidocaine from human serum samples. The developed methods

are recommended for quantifying systemic exposure and residual drug analysis of topical systems.


The authors are grateful to the National Institute for Pharmaceutical Technology and Education (NIPTE) and the US FDA for providing funds for this research. This study was funded by the FDA grant to NIPTE no. 1U01FD004275, subaward no. NIPTE-U01-Ll-2018-002


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