Pharmaceutical Science: Research Trends and Challenges Vol. 1

Cancer is a leading cause of mortality worldwide and comprises a broad group of diseases that can affect virtually any organ system. Gemcitabine is a potent cytotoxic agent classified as a pyrimidine nucleoside antimetabolite and is widely used to treat various metastatic and prostatic cancers. Approved by the FDA in 1996, it is indicated for the treatment of non-small-cell lung cancer, pancreatic cancer, and breast cancer. In advanced pancreatic adenocarcinoma (stage II, stage III, or metastatic stage IV), for which regional resection is no longer viable, gemcitabine often serves as a first-line treatment. As a prodrug, gemcitabine requires phosphorylation by deoxycytidine kinase to form its active intracellular metabolites and exert its therapeutic effects. This review aims to systematically summarise and critically evaluate analytical and bioanalytical methods for gemcitabine in pharmaceutical products and biological matrices reported from 2003 to 2023. The literature describes numerous methods for estimating gemcitabine, either alone or in combination with other agents. These methods include UV spectrophotometry, spectrofluorimetry, Fourier-transform infrared spectroscopy, high-performance liquid chromatography (HPLC), high-performance thin-layer chromatography (HPTLC), and advanced hyphenated techniques. In addition, this review evaluates the greenness profiles of reported analytical methods from 2003 to 2023 using the National Environmental Methods Index (NEMI), in alignment with the Sustainable Development Goals for 2030. The findings indicate that the reported UV spectroscopic methods are simple, accurate, precise, and cost-effective and employ different solvents while providing good recovery. The chromatographic methods reported across different studies represent a diverse range of analytical approaches that balance accuracy and precision, stability-indicating capability for detecting degradation products, short retention times for enhanced throughput, and adaptability to different matrices and pharmaceutical formulations. Recent advances in bioanalytical techniques, including UHPLC-MS/MS, HILIC, fluorescence-based sensors, and nanoparticle formulations, have improved the precision and efficiency of drug monitoring. Assessment of the greenness profiles using NEMI indicated that approximately 90% of the methods achieved 50% compliance with the NEMI criteria. The findings emphasise the need to develop more robust, efficient, and environmentally friendly methods, particularly sorbent-based microextraction techniques, which may support biomedical research. This review provides a useful overview for researchers and encourages the adoption of greener analytical approaches using environmentally preferable solvents for determining gemcitabine in biological matrices and pharmaceutical products.