Lachman Institute for Pharmaceutical Analysis, Long Island University, Brooklyn, NY, USA.
Synthetic Enabling Technologies, Product & Process Development, Drug Product Technologies, Amgen, Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.
Bioanalysis. 2023 May;15(10):553-566. doi: 10.4155/bio-2023-0034. Epub 2023 May 18.
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. 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. 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.
本工作旨在开发和验证敏感、高效的分析方法，以估算经皮给药系统给药后的系统药物暴露和残留药物。采用液液萃取技术从市售局部用制剂中提取利多卡因，并采用超高效液相色谱法进行分析。还开发了一种单独的 LC-MS/MS 方法用于分析人血清样品。所开发的方法成功地应用于估算两种市售产品中的利多卡因含量，产品 A 的结果为 97.4-104.0%，产品 B 的结果为 105.0-110.7%。LC-MS/MS 方法成功地分析了人血清样品中的利多卡因。所开发的方法推荐用于定量经皮给药系统的全身暴露和残留药物分析。
