A review of clinical, pharmacological and analytical aspects of smoking cessation pharmaceutical drugs

Cigarette smoking continues to be a major global health challenge and a leading cause of preventable morbidity and mortality. This review presents a concise overview of the clinical, pharmacological, and analytical aspects of drugs used for smoking cessation. It outlines the epidemiological burden of tobacco use and highlights key familial and sociocultural factors influencing smoking behavior, underscoring the need for effective therapeutic strategies. Established pharmacotherapies such as bupropion (BUP), Varenicline, Nortriptyline, and clonidine are discussed for their proven efficacy in smoking cessation. The review also evaluates advances in analytical techniques, including high-performance liquid chromatography (HPLC), liquid chromatography–tandem mass spectrometry (LC-MS/MS), and UV–visible spectrophotometry, emphasizing their roles in drug quantification, impurity profiling, and stability assessment. Recent developments in validated, stability-indicating analytical methods aligned with regulatory guidelines are highlighted, with applications in pharmacokinetics, bioequivalence studies, and routine quality control. Special focus is given to enantioselective analysis, forced degradation studies, and metabolite monitoring, particularly the nicotine metabolite ratio as a predictive biomarker for cessation outcomes. Emerging approaches such as combination therapies, innovations in transdermal drug delivery, and gender-specific responses are also discussed. Key validation parameters—specificity, precision, linearity, and robustness—are emphasized to ensure analytical reliability. Additionally, green chemistry tools like AES, AGREE, and MoGAPI are considered to evaluate environmental sustainability. Overall, this review integrates clinical insights with advanced analytical methodologies, promoting reliable, efficient, and environmentally conscious approaches for smoking cessation therapies.