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

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. (author)