CCD-Optimized High-Performance Thin-Layer Chromatographic Method for the Simultaneous Estimation of Candesartan Cilexetil and Metformin Hydrochloride in Mups Dosage Form
Abstract
Abstract Purpose Candesartan Cilexetil and Metformin Hydrochloride, when combined in a newer MUPS-based dosage form, present a need for an HPTLC method that can quantify both drugs at once. This work develops such a method, using Design of Experiment principles to optimize the mobile phase. Methods Central Composite Design (CCD) guided the optimization of the chromatographic conditions. Three variables were varied during this process: methanol proportion in the mobile phase, chamber saturation time, and distance traveled by solvent. Separation itself took place on aluminium plates pre-coated with silica gel 60 F254, with Methanol, CCl4, Ammonium acetate, and Ammonia combined in a 1.32:4.6:4.6:0.1 ratio to form the mobile phase. Candesartan Cilexetil was quantified between 120 and 280 ng/band, while Metformin Hydrochloride was quantified in the range of 2000–6000 ng/band; both were read at 248 nm. Results The bands were sharp and well resolved. Candesartan Cilexetil appeared at an Rf of 0.71 ± 0.02, and Metformin Hydrochloride at 0.30 ± 0.02 a clear separation between the two. The Calibration plots for both drugs showed strong linearity, with r² values of 0.9971 for Candesartan Cilexetil and 0.9912 for Metformin Hydrochloride. Precision, accuracy, robustness, specificity, and the limits of detection and quantification were all evaluated in line with ICH guidelines to validate the method. Conclusion These results confirm that a novel HPTLC method for simultaneously quantifying…
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