Green TLC-densitometric method for determination of cytarabine and granisetron in spiked human plasma: optimization and whiteness assessment

Abstract

Cytarabine (CYT) is a cornerstone in the treatment of acute myeloid leukemia (AML) and is often co-administered with granisetron (GRS) to manage chemotherapy-induced nausea and vomiting (CINV). A precise and sensitive thin-layer chromatographic (TLC) method was developed and validated for the simultaneous determination of CYT and GRS in spiked human plasma samples. Chromatographic separation was achieved by using a developing system consisting of ethyl acetate, ethanol, and ammonia (3:6.8:0.2, by volume), and detection was performed at 240 nm. The method exhibited linearity over the concentration ranges of 0.5-3.0 µg/band for the pure samples and 0.5-3.3 µg/band in spiked plasma for the analytes. The proposed method was validated in accordance with the guidelines of the U.S. Food and Drug Administration (FDA). Its environmental sustainability was evaluated using the Modified Green Analytical Procedure Index, Analytical Greenness Calculator, and Multicolor Assessment Index, demonstrating strong performance with minor areas for improvement. Notably, this study presents the first green TLC method for the simultaneous determination of CYT and GRS in spiked human plasma, offering a valuable tool for therapeutic drug monitoring during chemotherapy.