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.

中文翻译：

---

验证用于分析 [11C] 尼古丁的反相高效液相色谱 (RP-HPLC) 方法

必须使用经过验证的分析方法来准确和精确地确定用于人类给药的任何药物剂量的特性、纯度、强度和质量。因此，所有分析方法都必须根据 USP <1225> 和 ICH Q2R1 指南进行验证，以满足 FDA 和 EMA 的 cGMP 要求。开发了一种运行时间 <10 分钟的反相高效液相色谱分析方法，用于分析 [11C] 尼古丁。发现该分析方法对所研究浓度范围内的 [11C] 尼古丁、尼古丁和 (±) 去甲尼古丁具有特异性、准确、合适、稳健、精确和线性。还确定了 LOD 和 LOQ 值。