Method Development And Validation Of Imeglimin Hydrochloride Using High-Performance Thin-Layer Chromatography In Bulk And Tablet Dosage Form

A novel method for analyzing Imeglimin Hydrochloride, an oral antidiabetic agent has been developed and validated using High-Performance Thin Layer Chromatography (HPTLC) for both bulk and tablet forms. The method utilizes a mobile phase of acetone, methanol, toluene, and formic acid in specific proportions. Chromatographic separation was achieved on silica gel TLC plates with densitometry scanning at 244 nm, where the drug shows significant absorbance. Validation followed ICH Q2R1 guidelines, demonstrating satisfactory results for Linearity, Accuracy, Precision (intra- and inter-day), Limit of detection (LOD), Limit of quantitation (LOQ), and Robustness. The calibration curve was linear over the concentration range of 1000-5000 ng/band, with a regression equation of y = 2.9501x + 3834.2 and a correlation coefficient (R²) of 0.9942. Precision studies showed low % RSD values for intra-day and inter-day variations, confirming reliability. The LOD and LOQ were 1074.928 ng/spot and 3257.54 ng/spot, respectively. Recovery studies demonstrated the method's accuracy, with % recovery values near 100% at different spike levels. Robustness testing indicated the method's resilience to small, deliberate changes in experimental conditions, with % recovery within the acceptable limit of 2%. The developed HPTLC method offers a simple, cost-effective, and reliable means for quantitatively analyzing Imeglimin Hydrochloride in pharmaceutical formulations.