DOI 10.1016/j.jchromb.2026.125103
Eco-friendly appraised HPTLC strategy for the simultaneous determination of the newly approved meloxicam and rizatriptan mixture in their formulation.
Аннотация
Migraine is recognized as a major neurological disorder characterized by substantial global prevalence, affecting more than one billion individuals worldwide. In 2025, the FDA approved a novel fixed-dose mixture of rizatriptan (RIZ) and meloxicam (MEL) for managing acute migraine. In response, an affordable and sensitive TLC-densitometric strategy was developed for determining MEL and RIZ concurrently in their pure powders and recently approved formulation. The separation process was achieved on a 60F254 silica gel stationary phase employing a moving phase of methanol, ethyl acetate, and 25% aqueous ammonia (9:1:0.05, by volume). The medications were UV-scanned at 254.0 nm. Key chromatographic parameters influencing strategy performance were systematically investigated and optimized. Our strategy was fully validated, consistent with ICH standards, and demonstrated satisfactory linearity over concentration ranges of 2-12 μg/band for MEL and 1-6 μg/band for RIZ, along with good accuracy, robustness, precision, and selectivity, enabling reliable quantification without intrusion from common excipients. Furthermore, the environmental sustainability and overall analytical performance of our strategy were comprehensively assessed utilizing multiple appraisal tools, confirming its favorable environmental profile, balanced analytical performance, and practical applicability compared with previously documented methods. Compared with previously published LC methods, particularly UPLC, our strategy requires lower solvent consumption and reduced energy demand and generates less analytical waste owing to the simultaneous analysis of multiple samples on a single plate, while also offering greater operational simplicity. The ability to simultaneously estimate all analytes in a single TLC run cheaply renders our strategy efficient and well-suited for regular QC testing.
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