김지연 (중앙대학교 약학대학)

이동규 (중앙대학교 약학대학)

김지연 (중앙대학교 약학대학)

심민기 (중앙대학교 약학대학)

정승진 (중앙대학교 약학대학)

이동규 (중앙대학교 약학대학)

Nitrosamine drug substance-related impurities (NDSRIs) are formed by the incorporation of nitroso (NO) groups into the chemical structure of active pharmaceutical ingredient (API) and are being actively investigated due to their potential toxicity. Sertraline, a selective serotonin reuptake inhibitor (SSRI) antidepressant, is among the NDSRIs that should be managed. In this study, we developed liquid chromatography-electrospray ionization-tandem mass spectrometry (LC-ESI-MS/MS) based method for the quantification of N-nitroso sertraline in sertraline drugs. A comparative analysis of the three columns (Phenyl-Hexyl, C18 and HILIC) revealed that the Phenyl-Hexyl column provided the most effective separation of N-nitroso sertraline from the active pharmaceutical components. The analytical procedure, which utilized minimal sample preparation, was validated following standard guidelines for method validation. The developed method demonstrated excellent linearity (r² > 0.997), acceptable recovery and sensitivity, with a limit of detection (LOD) and limit of quantitation (LOQ) of 2 ng/mL and 5 ng/mL, respectively, aligning with the regulatory acceptable intake limits. It is expected that the validated method will have a substantial impact on the identification of NDSRIs, the monitoring of pharmaceuticals, and the reduction of impurities in pharmaceuticals. This research was supported by a grant (23194MFDS086) from Ministry of Food and Drug Safety in 2025.​